protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03926130 | 8.3.4 | Regulatory Reporting Requirements for SAEs | 8.3.4 Regulatory Reporting Requirements for SAEs Prompt notification by the investigator to the sponsor of an SAE as stated in Section [8.3](#page-78-0) and Section [8.3.2](#page-80-1) is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study interv... | [] |
NCT03926130 | 8.3.5 | Pregnancy Reporting | 8.3.5 Pregnancy Reporting For all pregnancies in female participants and female partners of male participants, details will be collected (via the procedures outlined in Section [8.3\)](#page-78-0) for pregnancies that begin at any point after the start of study drug and until at least 20 weeks after the participant's l... | [] |
NCT03926130 | 8.3.7.1 | Opportunistic Infections | 8.3.7.1 Opportunistic Infections Infections will be categorized by Lilly as opportunistic according to Opportunistic Infections and Biologic Therapies in Immune-Mediated Inflammatory Diseases: Consensus Recommendations for Infection Reporting during Clinical Trials and Postmarketing Surveillance by Winthrop et al. (201... | [] |
NCT03926130 | 8.3.7.2 | Systemic Allergic Reactions and Hypersensitivity Events | 8.3.7.2 Systemic Allergic Reactions and Hypersensitivity Events All biologic agents carry the risk of systemic allergic/hypersensitivity reactions. Clinical manifestations of these reactions may include but are not limited to: - Skin rash - Pruritus (itching) - Dyspnea - Urticarial (hives) - Angioedema (for example, sw... | [] |
NCT03926130 | 8.3.7.3 | Injection/Infusion Site Reactions | 8.3.7.3 Injection/Infusion Site Reactions Symptoms of a local injection/infusion site reaction may include erythema, induration, pain, pruritus, and edema at the site of the injection/infusion. If an injection/infusion site event is reported, the AE will be recorded, and additional data will be provided to the sponsor ... | [] |
NCT03926130 | 8.3.7.4 | Cerebro-cardiovascular Events Adjudication | 8.3.7.4 Cerebro-cardiovascular Events Adjudication Potential cerebro-cardiovascular events will be identified by the investigative site or by a medical review conducted by the sponsor or designee. Additional data about each identified potential event should be provided to the sponsor via specific event adjudication for... | [] |
NCT03926130 | 8.3.8 | Complaint Handling | 8.3.8 Complaint Handling Lilly collects product complaints on investigational products and drug delivery systems used in clinical studies in order to ensure the safety of study participants, monitor quality, and to facilitate process and product improvements. Participants will be instructed to contact the investigator ... | [] |
NCT03926130 | 8.4 | Treatment of Overdose | 8.4 Treatment of Overdose In case of suspected overdose, participants should be monitored for any signs or symptoms of adverse reactions or effects, and hematology, chemistry, vital signs, and oxygen saturation should be monitored; supportive care should be provided as necessary. The medical monitor and sponsor must be... | [] |
NCT03926130 | 8.5 | Pharmacokinetics | 8.5 Pharmacokinetics
Visits and times At the visits and times specified in the SoA (Section [1.3\)](#page-16-0), venous blood samples will be collected to determine the serum concentrations of mirikizumab. 
Collection, handling, and storage of samples Instructions for the collection and handli... | [
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"Additional samples",
"Blinding",
"Sample retention"
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NCT03926130 | 8.6 | Pharmacodynamics | 8.6 Pharmacodynamics See Section [8.8](#page-84-2) for biomarkers. | [] |
NCT03926130 | 8.7 | Pharmacogenomics | 8.7 Pharmacogenomics | [] |
NCT03926130 | 8.7.1 | Whole Blood Sample for Pharmacogenetic Research | 8.7.1 Whole Blood Sample for Pharmacogenetic Research A whole blood sample will be collected for pharmacogenetic analysis as specified in the SoA (Section [1.3\)](#page-16-0) where local regulations allow.
Sample use Samples will not be used to conduct unspecified disease or population genetic research either now or i... | [
"Sample use",
"Sample retention"
] |
NCT03926130 | 8.8 | Exploratory Biomarkers | 8.8 Exploratory Biomarkers Serum, plasma, whole blood RNA, whole blood for epigenetics, fecal matter, and gastrointestinal tissue samples for biomarker research will be collected at the visits and times specified in the SoA (Section [1.3\)](#page-16-0) where local regulations allow.
Sample use Biomarker research is pe... | [
"Sample use",
"Sample retention"
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NCT03926130 | 8.9 | Medical Resource Utilization and Health Economics | 8.9 Medical Resource Utilization and Health Economics Sites should provide information regarding healthcare visits, including hospitalizations and surgeries for CD, as instructed on the eCRF. | [] |
NCT03926130 | 9 | Statistical Considerations | 9 Statistical Considerations | [] |
NCT03926130 | 9.1 | Statistical Hypotheses | 9.1 Statistical Hypotheses The primary hypothesis that will be tested in this study is that mirikizumab is superior to placebo in the Primary Analysis Set on below co-primary endpoint. - Clinical response by PRO at Week 12 and endoscopic response at Week 52 - Clinical response by PRO at Week 12 and clinical remission b... | [] |
NCT03926130 | 9.2 | Sample Size Determination | 9.2 Sample Size Determination Approximately 3000 participants may be screened to achieve a total of approximately 1100 participants randomly assigned to study intervention. Based on a 6:3:2 randomization ratio, approximately 600 participants will be randomized to mirikizumab, 300 participants to ustekinumab, and 200 pa... | [] |
NCT03926130 | 9.3 | Populations for Analyses | 9.3 Populations for Analyses For purposes of analysis, the following populations are defined.
Intent-to-Treat (ITT) Population The ITT Population is defined as all randomized participants, even if the participant does not receive the correct treatment, or otherwise does not follow the protocol. Participants will be an... | [
"Intent-to-Treat (ITT) Population",
"Modified Intent-to-Treat (mITT) Population",
"Primary Analysis Set",
"Safety Population"
] |
NCT03926130 | 9.4 | Statistical Analyses | 9.4 Statistical Analyses | [] |
NCT03926130 | 9.4.1 | General Statistical Considerations | 9.4.1 General Statistical Considerations Statistical analysis of this study will be the responsibility of Lilly or its designee. A detailed SAP describing the statistical methodologies will be developed by the sponsor or its designee. Unless otherwise specified, efficacy analyses will be conducted on the Primary Analys... | [] |
NCT03926130 | 9.4.1.1 | Definition of Baseline | 9.4.1.1 Definition of Baseline Visit 2 (Week 0) is the baseline randomization visit. The centrally read baseline SES-CD score from the screening endoscopy is considered the baseline for endoscopic response and endoscopic remission. Daily diary entries obtained prior to Visit 2 are also considered baseline for clinical ... | [] |
NCT03926130 | 9.4.1.2 | Estimand | 9.4.1.2 Estimand The estimand (ICH 2017) associated with each endpoint/analysis is documented in the following places: - The population of interest is described in the inclusion/exclusion criteria (Section [5.1](#page-39-1) and Section [5.2\)](#page-44-0) and in "Populations for Analyses" (Section [9.3\)](#page-87-0) -... | [] |
NCT03926130 | 9.4.1.3 | Missing Data Imputation | 9.4.1.3 Missing Data Imputation Analysis of categorical efficacy and health outcomes variables will use a nonresponder imputation (NRI) method for missing data. A participant will be considered NR for the NRI-based analysis if he or she: - does not achieve the endpoint(s) being analyzed, - has missing data at time poin... | [] |
NCT03926130 | 9.4.1.4 | Multiple Comparisons/Multiplicity | 9.4.1.4 Multiple Comparisons/Multiplicity For testing the primary and major secondary hypotheses, a prespecified graphical scheme (Bretz et al. 2009, 2011) will be implemented to control the overall Type I error rate (FWER) at a 2-sided alpha level of 0.05 as described below: Two groups including co-primary and major s... | [] |
NCT03926130 | 9.4.2 | Treatment Group Comparability | 9.4.2 Treatment Group Comparability | [] |
NCT03926130 | 9.4.2.1 | Participant Disposition | 9.4.2.1 Participant Disposition The number of randomized participants (that is, participants in ITT) will be summarized by treatment group. Frequency counts and percentages of all participants who are randomized and complete the study or who discontinue the study or treatment intervention early will be presented. Reaso... | [] |
NCT03926130 | 9.4.2.2 | Participant Characteristics | 9.4.2.2 Participant Characteristics Demographic and baseline characteristics will be summarized descriptively by treatment group; no testing will be performed for baseline characteristics. For continuous measures, summary statistics will include sample size, mean, standard deviation, median, minimum, and maximum. For c... | [] |
NCT03926130 | 9.4.2.3 | Concomitant Therapy | 9.4.2.3 Concomitant Therapy Concomitant therapy will be collected at each visit, and the reported term will be classified by the WHO drug dictionary. A summary of preferred names of concomitant medication by treatment group will be generated for the mITT population. | [] |
NCT03926130 | 9.4.2.4 | Treatment Compliance | 9.4.2.4 Treatment Compliance Deviations from the prescribed dosage regimen (as described in Section [6.4\)](#page-54-0) will be described in a patient listing. Additional details will be described in the SAP. | [] |
NCT03926130 | 9.4.3 | Efficacy Analyses | 9.4.3 Efficacy Analyses Primary and secondary analyses will be based on the Primary Analysis Set (defined in Section [9.3\)](#page-87-0). | [] |
NCT03926130 | 9.4.3.1 | Primary Analyses | 9.4.3.1 Primary Analyses The co-primary endpoint is comprised of two separate endpoints: - the proportion of participants achieving clinical response by PRO at Week 12 and endoscopic response at Week 52, and - the proportion of participants achieving clinical response by PRO at Week 12 and clinical remission by CDAI at... | [] |
NCT03926130 | 9.4.3.2 | Secondary Analyses | 9.4.3.2 Secondary Analyses The CMH test, as described for primary analyses, will be used to analyze categorical secondary endpoints. The previously described MMRM model will be used to analyze continuous secondary endpoints. Additional analyses of the secondary efficacy and health outcome endpoints may be considered an... | [
"Noninferiority Analysis",
"Justification of Noninferiority Margin",
"CDAI Remission rates for Week 52 are estimated as follows:"
] |
NCT03926130 | 9.4.3.3 | Tertiary/Exploratory Analyses | 9.4.3.3 Tertiary/Exploratory Analyses The proportion of participants in response to histologic endpoints at Week 12 and Week 52 will be compared across treatment groups. Analysis details are specified in the SAP. Additional analyses of exploratory health outcome endpoints may be considered and will be fully detailed in... | [] |
NCT03926130 | 9.4.4 | Safety Analyses | 9.4.4 Safety Analyses Safety will be assessed by evaluating exposure, AEs, laboratory analytes, vital signs, and AESIs (Section [8.3.7\)](#page-81-2). Duration of exposure to therapy during the treatment periods will be calculated for each participant and summarized by treatment group. The AEs will be coded according t... | [] |
NCT03926130 | 9.4.5 | Pharmacokinetic/Pharmacodynamic Analyses | 9.4.5 Pharmacokinetic/Pharmacodynamic Analyses The PK of mirikizumab will be characterized using graphical evaluations and mixed-effect (population PK) modeling approaches. Various structural and error models will be evaluated during development of the mixed-effect model. Intrinsic factors (such as age, body weight, ge... | [] |
NCT03926130 | 9.4.6 | Evaluation of Immunogenicity | 9.4.6 Evaluation of Immunogenicity Frequencies and percentages will be tabulated for the following: - participants with preexisting ADA, and - participants who are treatment-emergent ADA positive (TE-ADA+) to mirikizumab. Treatment-emergent ADAs are defined as those with a titer 2-fold (1 dilution) greater than the min... | [] |
NCT03926130 | 9.4.7 | Other Analyses | 9.4.7 Other Analyses | [] |
NCT03926130 | 9.4.7.1 | Health Economics | 9.4.7.1 Health Economics The health outcome and quality of life measures including Urgency NRS, FACIT-Fatigue, EQ-5D-5L, WPAI-CD, SF-36, and IBDQ will be analyzed using methods described for continuous data as described for efficacy measures in Section [9.4.1.](#page-87-2) | [] |
NCT03926130 | 9.4.7.2 | Subgroup Analyses | 9.4.7.2 Subgroup Analyses Subgroup analyses for selected endpoints specified in Section [3](#page-27-0) will be conducted. Additional subgroup analyses will be conducted for the co-primary and selected secondary endpoints. Subgroups to be evaluated may include gender, age, body weight, race, ethnicity, geographic regio... | [] |
NCT03926130 | 9.5 | Interim Analyses | 9.5 Interim Analyses A primary database lock is planned after all participants complete the Week 52 visit or the ETV. The analysis based on data from the primary database lock will be conducted by the sponsor or a designee and no multiplicity adjustment will be implemented. The final database lock will occur after all ... | [] |
NCT03926130 | 10 | Supporting Documentation and Operational Considerations | 10 Supporting Documentation and Operational Considerations | [] |
NCT03926130 | 10.1 | Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | 10.1 Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | [] |
NCT03926130 | 10.1.1 | Regulatory and Ethical Considerations | 10.1.1 Regulatory and Ethical Considerations This study will be conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) Internation... | [] |
NCT03926130 | 10.1.2 | Informed Consent Process | 10.1.2 Informed Consent Process The investigator or his or her representative will explain the nature of the study to the participant or his or her legally authorized representative, explain the risks and benefits of participating in the study, and answer all questions regarding the study. Participants must be informed... | [] |
NCT03926130 | 10.1.3 | Data Protection | 10.1.3 Data Protection Participants will be assigned a unique identifier by the investigator. Any participant records or datasets that are transferred to the sponsor will contain the identifier only; participant names or any information which would make the participant identifiable will not be transferred. The particip... | [] |
NCT03926130 | 10.1.4 | Committees Structure | 10.1.4 Committees Structure
Cerebro-Cardiovascular Adjudication Committee The role of the committee is described in Section [8.3.7.4.](#page-82-2)
Data Monitoring Committee A DMC consisting of members external to Lilly will be established. The purpose of the DMC is to conduct periodic monitoring of clinical trial dat... | [
"Cerebro-Cardiovascular Adjudication Committee",
"Data Monitoring Committee"
] |
NCT03926130 | 10.1.5 | Dissemination of Clinical Study Data | 10.1.5 Dissemination of Clinical Study Data
Report Preparation The CSR coordinating investigator will sign the final CSR for this study, indicating agreement that, to the best of his or her knowledge, the report accurately describes the conduct and results of the study
Public Access to Reports and Data
Reports The s... | [
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NCT03926130 | 10.1.6 | Data Quality Assurance | 10.1.6 Data Quality Assurance To ensure accurate, complete, and reliable data, Lilly or its representatives will do the following: - provide instructional material to the study sites, as appropriate - provide sponsor start-up training to instruct the investigators and study coordinators. This training will give instruc... | [
"Data Capture System"
] |
NCT03926130 | 10.1.7 | Source Documents | 10.1.7 Source Documents Source documents provide evidence for the existence of the participant and substantiate the integrity of the data collected. Source documents are filed at the investigator's site. Data reported on the eCRF or entered in the eCRF that are transcribed from source documents must be consistent with ... | [] |
NCT03926130 | 10.1.8 | Study and Site Closure | 10.1.8 Study and Site Closure | [] |
NCT03926130 | 10.1.8.1 | Discontinuation of the Study | 10.1.8.1 Discontinuation of the Study The study will be discontinued if Lilly or its designee judges it necessary for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and GCP. | [] |
NCT03926130 | 10.1.8.2 | Discontinuation of Study Sites | 10.1.8.2 Discontinuation of Study Sites Study site participation may be discontinued if Lilly or its designee, the investigator, or the ERB of the study site judges it necessary for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and GCP. | [] |
NCT03926130 | 10.1.9 | Publication Policy | 10.1.9 Publication Policy The publication policy is described in the letters of agreement between the sponsor and the investigators and institutions. | [] |
NCT03926130 | 10.2 | Appendix 2: Clinical Laboratory Tests | 10.2 Appendix 2: Clinical Laboratory Tests
Clinical Laboratory Tests Hematology a,b Clinical Chemistry a,b Hemoglobin Serum Concentrations of: Hematocrit Sodium Erythrocyte count (RBCs) Chloride Mean cell volume Bicarbonate Mean cell hemoglobin Potassium Mean cell hemoglobin concentration Total bilirubin Leukocytes (W... | [
"Clinical Laboratory Tests"
] |
NCT03926130 | 10.3 | Appendix 3: Hepatic Monitoring Tests for Treatment Emergent Abnormality | 10.3 Appendix 3: Hepatic Monitoring Tests for Treatment Emergent Abnormality Selected tests may be obtained in the event of a treatment-emergent hepatic abnormality and may be required in follow-up with participants in consultation with the medical monitor of Lilly or its designee. These tests will be performed at a Li... | [] |
NCT03926130 | 10.4 | Appendix 4: Risk Factors for Latent Tuberculosis Infection | 10.4 Appendix 4: Risk Factors for Latent Tuberculosis Infection
Risk Factors for Latent Tuberculosis Infection (LTBI) Household contact or recent exposure to an active case Birth or residency in a high burden country (>20/100,000) Residents and employees of high-risk congregate settings, for example, prisons, homeless... | [
"Risk Factors for Latent Tuberculosis Infection (LTBI)"
] |
NCT03926130 | 10.5 | Appendix 5: Examples of Infections that May Be Considered Opportunistic in the Setting of Biologic Therapy | 10.5 Appendix 5: Examples of Infections that May Be Considered Opportunistic in the Setting of Biologic Therapy This table is provided to aid the investigator in recognizing infections that may be considered opportunistic in the context of biologic therapy, for the purposes of exclusion criteria. This list is not exhau... | [] |
NCT03926130 | 10.6 | Appendix 6: Prohibited Medications | 10.6 Appendix 6: Prohibited Medications This section outlines medications that are prohibited during the treatment phase of the study and during washout periods prior to the screening endoscopy, if applicable. Use of the medications listed in this appendix is allowed at the discretion of the investigator after a partic... | [] |
NCT03926130 | 10.7 | Appendix 7: Permitted Medications | 10.7 Appendix 7: Permitted Medications | Drug Class | Guidancefor Use | |-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03926130 | 10.8 | Appendix 8: Patient-Reported Outcome Instruments | 10.8 Appendix 8: Patient-Reported Outcome Instruments This appendix describes PRO instruments used in this study. For the physician items of the CDAI and other clinician efficacy assessments, see Section [8.1.](#page-64-1) | Daily Diary (eDiary) | Tablet Device | |-------------------------------------------------------... | [] |
NCT03926130 | 10.9 | Appendix 9: Additional Information on the Columbia Suicide Severity Rating Scale, and Quick Inventory of Depressive Symptomatology (selfreport) | 10.9 Appendix 9: Additional Information on the Columbia Suicide Severity Rating Scale, and Quick Inventory of Depressive Symptomatology (selfreport)
Columbia Suicide Severity Rating Scale The C-SSRS was developed by the National Institute of Mental Health Treatment of Adolescent Suicide Attempters trial group for the ... | [
"Columbia Suicide Severity Rating Scale",
"Quick Inventory of Depressive Symptomatology—Self-Report (16 Items)"
] |
NCT03926130 | 10.10 | Appendix 10: Definitions and Selected Abbreviations | 10.10 Appendix 10: Definitions and Selected Abbreviations Term Definition ADA anti-drug antibody ADR Adverse drug reaction AE adverse event: Any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with ... | [] |
NCT03926130 | 10.11 | Appendix 11: Protocol Amendment History | 10.11 Appendix 11: Protocol Amendment History The Protocol Amendment Summary of Changes Table for the current amendment is located directly before the Table of Contents (TOC).
Amendment [a] This amendment is considered to be Overall Rationale for the Amendment: The overall changes and rationale for the changes made to... | [
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NCT03926130 | 11 | References | 11 References - Alosh M, Bretz F, Huque M. Advanced multiplicity adjustment methods in clinical trials. Stat Med. 2014;33(4):693-713 - [APA] American Psychiatric Association. Diagnostic and statistical manual of mental disorders, fifth edition (DSM-V). Arlington, VA: American Psychiatric Publishing. 2013. - Barrett JC,... | [
"Signature Page for VV-CLIN-019253 v1.0"
] |
NCT03940963 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT03940963 | 1.1 | Background | 1.1 Background A neuroma is formed when a peripheral nerve's continuity is substantially disrupted or injured. Nerve trauma types include cut nerves as in amputations or autograft sites, crushed nerves in carpal tunnel syndrome, or stretched nerves from high velocity accidents. When a disrupted nerve cannot be repaired... | [] |
NCT03940963 | 1.2 | Product Description | 1.2 Product Description Axoguard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surroundin... | [] |
NCT03940963 | 1.3 | Risk Analysis | 1.3 Risk Analysis Axoguard® Nerve Cap is contraindicated for use in any patient for whom soft tissue implants are contraindicated; this includes any pathology that would limit the blood supply and compromise healing or evidence of a current infection. Axoguard® Nerve Cap is derived from a porcine small intestinal submu... | [] |
NCT03940963 | 1.3.1 | Preclinical Testing for Axoguard® Nerve Cap | 1.3.1 Preclinical Testing for Axoguard® Nerve Cap Comprehensive in vitro and in vivo biocompatibility evaluations provide support that Axoguard® Nerve Cap is safe for use in humans. Additionally, in vivo testing utilizing well established and validated animal models has demonstrated efficacy in its intended use to reco... | [] |
NCT03940963 | 2 | Manufacturing Controls | 2 Manufacturing Controls Axoguard® Nerve Cap is manufactured in accordance with current good manufacturing practices (cGMPs) for medical devices. The biomaterial undergoes a thorough disinfection, decellularization, and viral inactivation process. As a final step in the process, the biomaterial is sterilized via valida... | [
"1.3.3 Previous Clinical Experience General Use",
"1.3.4 Published Clinical Studies",
"Axoguard® Nerve Connector:",
"Axoguard® Nerve Protector:"
] |
NCT03940963 | 2 | STUDY OBJECTIVES 2.1 Primary Objective | 2.STUDY OBJECTIVES 2.1 Primary Objective The primary efficacy objective of the pilot phase of this study is to evaluate the difference in pain scores from baseline at 3 months for subjects receiving Axoguard® Nerve Cap; The primary efficacy objective of the comparative phase is the difference in pain assessments at 12 ... | [] |
NCT03940963 | 2.2 | Secondary Objectives | 2.2 Secondary Objectives The secondary objectives of this study are to compare degree of recovery over time (reduction in pain); quality of life dato: | | [] |
NCT03940963 | 3 | STUDY DESIGN | 3.STUDY DESIGN | [] |
NCT03940963 | 3.1 | Description of Design | 3.1 Description of Design This is a multicenter, prospective, randomized, controlled, subject blinded comparative parallel group study in patients presenting with symptomatic neuroma (verified by diagnostic block or imaging (US or MRI confirmation) with a baseline pain level of >65 mm on a 100 mm Visual Analog Scale (V... | [] |
NCT03940963 | 3.2 | Study Treatment - Identification of Products | 3.2 Study Treatment - Identification of Products | [] |
NCT03940963 | 3.2.1 | Study Product | 3.2.1 Study Product Description: Axoguard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the s... | [] |
NCT03940963 | 3.2.2 | Control | 3.2.2 Control Description: Standard surgical treatment with neurectomy. Neurectomy is a surgical treatment for symptomatic neuroma. It entails neuroma excision with high transection of the nerve. The goal is to relocate the nerve stump proximally into an area more protected by muscle and soft tissue, where it is less l... | [] |
NCT03940963 | 3.3 | Study Population | 3.3 Study Population Adult male and female subjects (age ≥ 18 years old) with symptomatic neuroma in the foot or ankle to at least one nerve where the nerve cannot be repaired to a distal nerve end. | [] |
NCT03940963 | 3.4 | Eligibility Criteria | 3.4 Eligibility Criteria | [] |
NCT03940963 | 3.4.1 | Informed Consent | 3.4.1 Informed Consent Authorized written informed consent (witnessed, where required by law or regulation) will be obtained from all subjects before any study related procedures are performed. Investigators may discuss the availability of the study and the possibility for entry with a potential subject prior to obtain... | [] |
NCT03940963 | 3.4.2 | Inclusion Criteria | 3.4.2 Inclusion Criteria To be considered for enrollment, subjects must meet the following inclusion criteria:
Table 3.4.2-1: Inclusion Criteria
Potential Subjects must: - 1. Be able and willing to provide documented informed consent prior to the conduct of any study procedures; - 2. Be an adult male or non-pregnant ... | [
"Table 3.4.2-1: Inclusion Criteria",
"Potential Subjects must:"
] |
NCT03940963 | 3.4.3 | Exclusion Criteria | 3.4.3 Exclusion Criteria To be included in the study, the following criteria must not occur:
Table 3.4.3-1 Exclusion Criteria
Potential subjects must not: - 1. Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions; - 2. Have biomechanical pathology and ass... | [
"Table 3.4.3-1 Exclusion Criteria",
"Potential subjects must not:"
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NCT03940963 | 3.4.4 | Enrollment in Study | 3.4.4 Enrollment in Study | [] |
NCT03940963 | 3.4.4.1 | Treatment of Multiple Neuromas | 3.4.4.1 Treatment of Multiple Neuromas In instances where subjects have multiple neuromas in the foot/ankle, the surgeon must identify the target nerve for inclusion in this study, and agree to treat all additional neuromas as per the randomization assignment. Additionally, if subjects are diagnosed with bilateral neur... | [] |
NCT03940963 | 3.4.4.2 | Subject Screening and Numbering | 3.4.4.2 Subject Screening and Numbering After the subject has signed an IRB-approved informed consent form, he/she will be assigned a unique screening number. At each site, the screening numbers will start with S001. Subjects who meet the inclusion and exclusion criteria will be eligible for the study. In the comparati... | [] |
NCT03940963 | 3.4.4.3 | Subject Withdrawal or Discontinuation | 3.4.4.3 Subject Withdrawal or Discontinuation If a subject discontinues early from the study, the reason should be recorded in source documentation and the CRF. If the subject is withdrawn due to an adverse event, the adverse event should be indicated as the reason for withdrawal. All subjects have the right to withdra... | [] |
NCT03940963 | 3.4.4.4 | Subject Replacement | 3.4.4.4 Subject Replacement Once a subject is randomized, they may not be replaced. | [] |
NCT03940963 | 3.5 | Study Endpoints | 3.5 Study Endpoints | [] |
NCT03940963 | 3.5.1 | Safety Endpoints | 3.5.1 Safety Endpoints
Primary Safety Endpoint - 1. The rate of occurrence of Serious Adverse Events (SAEs) at 3 months - 2. The rate of occurrence of Adverse Experiences (AEs) or Unanticipated Adverse Device Effects at 3 months
Secondary Safety Endpoints 1. The rate of occurrence of SAEs, AEs and/or UADEs at 6, 9 an... | [
"Primary Safety Endpoint",
"Secondary Safety Endpoints"
] |
NCT03940963 | 3.5.2 | Efficacy Endpoints | 3.5.2 Efficacy Endpoints
Primary Efficacy Endpoints - 1. The change in VAS score at 3 months compared to baseline (pilot phase) - 2. The change in VAS score at 12 months compared to baseline (comparative phase)
Secondary Efficacy Endpoints - The change in VAS score at 1, 3, 6, 9 and 12 months compared to baseline 1. ... | [
"Primary Efficacy Endpoints",
"Secondary Efficacy Endpoints"
] |
NCT03940963 | 3.6.1 | Pain Assessments — VAS and PROMIS® | 3.6.1 Pain Assessments — VAS and PROMIS® Pain Assessments (VAS and PROMIS®) will be completed by the subject at the screening visit and all six (6) follow-up visits after the Daily Pain Diary review. Pain assessments may also be done on the operative day (but prior to nerve block or surgical intervention) if the nerve ... | [] |
NCT03940963 | 3.6.2.1 | Foot Health Status Questionnaire (FHSQ) | 3.6.2.1 Foot Health Status Questionnaire (FHSQ) The FHSQ was developed to help better measure responsiveness in overall foot health status in 4 areas (foot function, foot health, footwear and foot pain).>® The FHSQ's 4 scale have shown to be better predictors of foot responsiveness than other index rating scores.\® The... | [] |
NCT03940963 | 3.6.5 | Concomitant Medication Log and Daily Pain Medication Diary (Quantity and Class) | 3.6.5 Concomitant Medication Log and Daily Pain Medication Diary (Quantity and Class) Concomitant Medication logs and Daily Pain Medications Diaries (quantity and class of pain medication treatments) being prescribed/administered by the subject will be collected. A Daily Pain Medication Diary will be provided to each s... | [] |
NCT03940963 | 3.6.8 | Daily Pain Diary | 3.6.8 Daily Pain Diary A daily pain diary will be provided to each subject at the Screening visit (visit 1), and a new diary will be dispensed to the subject at Visits 2 through 7 to track incidence, frequency and severity of pain (using a 10-point scale) on a daily basis. Similar to the pain medication diaries, subjec... | [] |
NCT03940963 | 3.7 | Measures to Minimize/Avoid Bias | 3.7 Measures to Minimize/Avoid Bias The following control measures will be put in place to minimize and/or avoid bias within the study. o All Investigators selected for participation must have completed a foot and/or microsurgical - fellowship. o Investigators will have prior experience performing neurectomy procedures... | [] |
NCT03940963 | 3.7.1 | Blinding | 3.7.1 Blinding 'While blinding the surgeon to treatment is not possible, blinding the subject is possible and all efforts should be taken to preserve this blind. Randomization will be used to assign the subject to a study group intra-operatively therefore ensuring the subject is blinded to their treatment assignment. D... | [] |
NCT03940963 | 3.8 | Randomization (comparative phase only) | 3.8 Randomization (comparative phase only) In the pilot phase, the initial 15 subjects in will be assigned to open label treatment with Axoguard® Nerve Cap. In the subsequent comparative phase, subjects will be centrally randomized using an Interactive Web Response System (IWRS), OpenClinica, to undergo either neurecto... | [] |
NCT03940963 | 3.9 | Study Procedures | 3.9 Study Procedures After written informed consent is obtained, a pre-operative screening visit (visit 1) will be conducted to assess eligibility for the study. At the Operative Visit (visit 2), pre-operative preparation, debridement and mobilization of the nerve stump will be per performed in accordance with the Inve... | [] |
NCT03940963 | 3.9.1 | Visit 1: Pre-Operative Screening | 3.9.1 Visit 1: Pre-Operative Screening Once informed consent has been obtained, the subject will be assigned a screening number and the following pre-operative assessments will be performed at the Pre-Operative Screening visit - 1. Assess Inclusion/Exclusion criteria - 2. Obtain relevant vital signs (height / weight) -... | [] |
NCT03940963 | 3.9.2 | Visit 2: Operative Day, Day 0 | 3.9.2 Visit 2: Operative Day, Day 0 The following will be collected during the Operative Day: - 1. Verify Inclusion/Exclusion criteria - 2. Obtain Vital signs - 3. Document Operative Information: description of nerve injury presentation and location, and implantation information – see sequence below19 - 4. Randomizatio... | [
"The following sequence of steps will take place intraoperatively for the Nerve Cap group:19"
] |
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