protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03734588 | 6.6 | Day -2 | 6.6 Day -2 | [] |
NCT03734588 | 6.7 | Dosing Day Assessments (Day 0) | 6.7 Dosing Day Assessments (Day 0) If a participant has a bleeding event between the screening period and the start of Day 0, he should be treated with his previous FVIII product. All bleeding events and related treatment should be recorded in the electronic case report form (eCRF). All participants will administer a p... | [] |
NCT03734588 | 6.7.1 | FVIII Dosing | 6.7.1 FVIII Dosing At FVIII dosing: • Verify the administration (self-infused or assisted by site staff) of a single prophylactic IV infusion of 50 IU/kg of FVIII product on the morning of Day 0.   | [] |
NCT03734588 | 6.7.3 | Vector Dosing | 6.7.3 Vector Dosing
Assessments before SPK-8016 Vector infusion: - Review Inclusion/ Exclusion Criteria - Measure vital signs (blood pressure, pulse, respiratory rate, and oral/temporal temperature) - Perform physical examination, including weight - Hemophilia Activities List, Health Economic Assessment - Record AEs a... | [
"Assessments before SPK-8016 Vector infusion:",
"Assessments during Vector infusion:",
"Assessments after completion of Vector infusion:"
] |
NCT03734588 | 6.7.4 | Day 1 | 6.7.4 Day 1 Measure vital signs 24 (± 1 hr) hours post-SPK-8016 dose (blood pressure, pulse, respiratory rate, and oral/temporal temperature). Obtain blood samples for central laboratory evaluation at all visits, unless otherwise noted: - Immune profiling (CL) (24 (±1) hours post vector infusion) - PAX Gene (CL) (24 (±... | [] |
NCT03734588 | 6.8 | Follow-up Observation Period (Weeks 1-52) | 6.8 Follow-up Observation Period (Weeks 1-52) Visits during the follow-up period may occur at either the vector-administration or follow-up center. Any visit requiring a physical exam must be performed at the study center. All other visits without a physical exam may be performed by a qualified and trained in-home serv... | [] |
NCT03734588 | 6.8.1 | Days 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38, 42, 45, 49, 52, 56, 59, 63, 66, 70, 73, 77, 84 (± 2 days) | 6.8.1 Days 3, 7, 10, 14, 17, 21, 24, 28, 31, 35, 38, 42, 45, 49, 52, 56, 59, 63, 66, 70, 73, 77, 84 (± 2 days) A minimum of twice weekly visits is required from Weeks 1-11 to monitor for a potential rise in hepatic transaminases and/or loss of FVIII transgene expression. Visits at Weeks 1-11 may be performed by an in-h... | [] |
NCT03734588 | 6.8.2 | Weeks 14, 16, 18, 22, 26, 30, 34, 40, 46, 52/End of Study (± 2 weeks) | 6.8.2 Weeks 14, 16, 18, 22, 26, 30, 34, 40, 46, 52/End of Study (± 2 weeks) Visits will occur every 2 weeks from Weeks 12-16 and every 4 weeks from Weeks 18-34, then every 6 weeks from Weeks 40-52/ EOS. If immunomodulation is initiated, weekly visits should continue to collect transaminases, FVIII, and Immunology. Week... | [] |
NCT03734588 | 7 | STUDY INTERVENTION | 7 STUDY INTERVENTION | [] |
NCT03734588 | 7.1 | Description of Study Drug | 7.1 Description of Study Drug | Study Drug Name: | SPK-8016 | | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03734588 | 7.2 | Study Drug Doses | 7.2 Study Drug Doses The proposed SPK-8016 doses for this study are: - Starting dose (5x1011 vg/kg) - Middle dose (1x1012vg/kg) - High dose (2x1012 vg/kg) Any decision to add a fourth dose level or further expand one of the existing protocol-defined dose levels will be made in consultation with the DMC. Once at least 2... | [] |
NCT03734588 | 7.6 | Study Drug Preparation, Handling and Disposal | 7.6 Study Drug Preparation, Handling and Disposal | [] |
NCT03734588 | 7.6.1 | Study Drug Preparation | 7.6.1 Study Drug Preparation SPK-8016 is derived from a virus and should be considered and handled as an infectious agent. A qualified pharmacist with specific training on this protocol will be responsible for vector receipt from the Sponsor, storage, documentation of traceability of investigational product at the inve... | [] |
NCT03734588 | 7.6.2 | Study Drug Handling and Disposal | 7.6.2 Study Drug Handling and Disposal The Investigator or designee must confirm appropriate temperature conditions have been maintained during transit and on-site storage for all study drug and immunomodulators received, and any discrepancies are reported and resolved before use of the study drug or immunomodulator. I... | [] |
NCT03734588 | 7.6.3 | Accountability and Destruction | 7.6.3 Accountability and Destruction The Investigator, institution, or the head of the medical institution (where applicable) is responsible for study drug accountability, reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposal records). Accountability must be maintained for SPK-8016 a... | [] |
NCT03734588 | 7.7 | Labeling | 7.7 Labeling The SPK-8016 product label includes investigational product name; manufacturer; specific lot number; date of manufacture; vial number; storage instructions; and investigational product warning. The immunomodulator product labels include similar information. The Pharmacy Brochure will contain copies of all ... | [] |
NCT03734588 | 7.8 | Study Compliance | 7.8 Study Compliance Following the administration of SPK-8016, participants will be followed according to the protocol schedule of assessments. Participants will be encouraged to follow-up completely and according to study endpoints. Non-adherence to the protocol will be reported to the relevant regulatory groups overs... | [] |
NCT03734588 | 7.9 | Prior and Concomitant Medications | 7.9 Prior and Concomitant Medications The use of concomitant therapies or procedures, as defined below, must be recorded on the participant's eCRF. AEs related to administration of these therapies or procedures must be documented on the appropriate eCRF. | [] |
NCT03734588 | 7.9.1 | Concomitant Therapy | 7.9.1 Concomitant Therapy Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or herbal supplements) that the participant is receiving 30 days prior to screening, at the time of enrollment or during the study must be recorded in the eCRF along with: - Reason for use - Dates of... | [] |
NCT03734588 | 7.9.2 | Permitted Therapy | 7.9.2 Permitted Therapy During the study, participants are requested to suspend their prophylaxis regimen, but participants are permitted to take: • FVIII product, as needed for bleeding. Usage of clotting factors (product, date, dosage, reason) will be recorded in the infusion log. The use of FVIII for prophylaxis is ... | [] |
NCT03734588 | 7.9.3 | Prohibited Therapy | 7.9.3 Prohibited Therapy The following concomitant medications are not permitted during the study: - Acetylsalicylic acid (aspirin) or ibuprofen; however, other non-steroidal antiinflammatory drugs are permitted. - Routine prophylactic treatment with FVIII product after Day 14 post vector infusion unless clinically ind... | [] |
NCT03734588 | 7.9.4 | Concomitant Procedures | 7.9.4 Concomitant Procedures A concomitant procedure is any therapeutic intervention (e.g., surgery/biopsy, physical therapy, tooth extraction) or diagnostic assessment (e.g., blood gas measurement, bacterial cultures) performed between the time the participant is enrolled (at screening) and the last study visit (Week ... | [] |
NCT03734588 | 8 | DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | 8 DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | [] |
NCT03734588 | 8.1 | Participant Discontinuation/Withdrawal from the Study | 8.1 Participant Discontinuation/Withdrawal from the Study Participants may withdraw from the study at any time at their own request or may be withdrawn at any time at the discretion of the Investigator for safety, behavioral, compliance, or administrative reasons. If the participant withdraws consent for disclosure of ... | [] |
NCT03734588 | 8.2 | Early Termination Study Visit | 8.2 Early Termination Study Visit If the participant withdraws after receiving the investigational product, the early termination study procedures should be identical to those of the EOS visit. If the participant withdraws before receiving the investigational product, early termination study procedures are not necessar... | [] |
NCT03734588 | 8.3 | Lost to Follow Up | 8.3 Lost to Follow Up A participant will be considered lost to follow-up if he/she repeatedly fails to return for scheduled visits and there is documentation that he/she has been unable to be contacted by the study site. The following actions must be taken if a participant fails to return to the clinic for a required s... | [] |
NCT03734588 | 9 | ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS | 9 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS The definitions of an AE or SAE can be found in the following sections. An AE will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any qualified designees are respon... | [] |
NCT03734588 | 9.1 | Definitions | 9.1 Definitions | [] |
NCT03734588 | 9.1.1 | Adverse Event | 9.1.1 Adverse Event An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laborator... | [
"Events meeting the AE definition include:",
"Events that do NOT meet the AE definition include:"
] |
NCT03734588 | 9.1.2 | Definition of SAE | 9.1.2 Definition of SAE If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). An SAE is defined as any untoward medical occurrence that, at any dose meets the ... | [
"• Results in death",
"• Is life-threatening",
"• Requires inpatient hospitalization or prolongation of existing hospitalization",
"• Results in persistent or significant disability/incapacity"
] |
NCT03734588 | 9.1.3 | Adverse Events of Special Interest (AESI) | 9.1.3 Adverse Events of Special Interest (AESI) There are several AEs that will be monitored closely during the study as adverse events of special interest (AESIs) to enable an adequate risk-benefit evaluation of SPK-8016 versus standard therapy during the study and additional data may be requested for these events. Th... | [] |
NCT03734588 | 9.2 | Recording of AE and/or SAE | 9.2 Recording of AE and/or SAE When an AE/SAE occurs, it is the responsibility of the Investigator to review all documentation (e.g., hospital progress notes, laboratory reports, and diagnostics reports) related to the event. - The Investigator will then record all relevant AE/SAE information in the eCRF. - It is not a... | [] |
NCT03734588 | 9.3 | Safety Classifications | 9.3 Safety Classifications | [] |
NCT03734588 | 9.3.1 | Assessment of Intensity | 9.3.1 Assessment of Intensity The Investigator will assess the intensity for each AE and SAE reported during the study and assign it to one of the following categories: - Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. - Moderate: An e... | [] |
NCT03734588 | 9.3.2 | Assessment of Causality | 9.3.2 Assessment of Causality The Investigator is obligated to assess the relationship between investigational product (or administration procedure or study required concomitant therapy) and occurrence of each AE/SAE. The causality assessment is one of the criteria used when determining regulatory reporting requirement... | [] |
NCT03734588 | 9.4 | Follow-up and Reporting Requirements | 9.4 Follow-up and Reporting Requirements | [] |
NCT03734588 | 9.4.1 | Follow-up of AEs and SAEs | 9.4.1 Follow-up of AEs and SAEs After the initial AE/SAE report, the Investigator is required to proactively follow each participant at subsequent visits/contacts. All AE/SAEs will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. New or updated info... | [] |
NCT03734588 | 9.4.2 | Reporting of SAEs | 9.4.2 Reporting of SAEs Reporting to the Sponsor/designee via a SAE form will be performed as follows: - All SAEs must be recorded in the eCRF and reported in the SAE form to the Sponsor within 24 hours of site awareness via email to Spark@primevigilance.com. - In rare circumstances where SAE information is discussed d... | [] |
NCT03734588 | 9.5 | Time Period and Frequency for Collecting AE and/or SAE Information | 9.5 Time Period and Frequency for Collecting AE and/or SAE Information | [] |
NCT03734588 | 9.5.1 | Time Period and Frequency for Collecting of AEs and SAEs | 9.5.1 Time Period and Frequency for Collecting of AEs and SAEs All AEs and SAEs will be recorded during the period from the signing of the informed consent form (ICF) until the EOS visit at the time points specified in the Schedule of Events. Medical occurrences that begin before signing of the informed consent form wi... | [] |
NCT03734588 | 9.5.2 | Collection of AEs and SAEs information after conclusion of the study | 9.5.2 Collection of AEs and SAEs information after conclusion of the study Investigators are not obligated to actively seek AE or SAE information after conclusion of the study participation. However, if the Investigator learns of any SAE, including a death, at any time after a participant has been discharged from the s... | [] |
NCT03734588 | 9.5.3 | Regulatory Reporting Requirements for SAEs | 9.5.3 Regulatory Reporting Requirements for SAEs - Prompt notification by the Investigator to the Sponsor of a SAE is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study intervention under clinical investigation are met. - The Sponsor has a legal... | [] |
NCT03734588 | 9.5.4 | Pregnancy | 9.5.4 Pregnancy Participants included in this study are exclusively male. Should a female partner of the participant become pregnant during the study, the Investigator must notify Spark within 14 days of the Investigator becoming aware of the pregnancy. The participant and female partner must sign an IRB approved pregn... | [] |
NCT03734588 | 9.6 | Treatment of Overdose | 9.6 Treatment of Overdose The chance of overdosing is remote as the SPK-8016 gene therapy product is a one-time administration with no participant access to the study drug. Furthermore, SPK-8016 will be prepared by trained pharmacy staff and verified by a trained pharmacist before administration to the participant. Nev... | [] |
NCT03734588 | 10 | STATISTICAL CONSIDERATIONS | 10 STATISTICAL CONSIDERATIONS | [] |
NCT03734588 | 10.1 | Statistical Hypotheses | 10.1 Statistical Hypotheses No statistical hypotheses will be tested as part of this protocol. This study will be used to establish an initial safety and efficacy profile of SPK-8016. | [] |
NCT03734588 | 10.2 | Sample Size Determination | 10.2 Sample Size Determination The sample size is based on the need to establish the initial safety and efficacy profile of SPK-8016. Up to 40 eligible participants will be dosed. If more than 40 eligible participants are to be dosed, regulator(s) will be informed along with DMC recommendation. Because the size of the ... | [] |
NCT03734588 | 10.3 | Populations for Analyses | 10.3 Populations for Analyses The Full Analysis Set (FAS) is defined as all participants who receive the infusion of SPK-8016. The analyses of efficacy will be performed in this population, including the evaluation of vectorderived FVIII:C activity for estimation of peak and steady-state activity levels. As this is an ... | [] |
NCT03734588 | 10.4 | Demography and Baseline Disease Characteristics | 10.4 Demography and Baseline Disease Characteristics All participants who receive the infusion of SPK-8016 will be included in the analysis of demography and baseline disease characteristics. Demographic and other baseline characteristics will be summarized using descriptive statistics. Data to be tabulated will includ... | [] |
NCT03734588 | 10.5 | Primary and Secondary Endpoints | 10.5 Primary and Secondary Endpoints | [] |
NCT03734588 | 10.5.1 | Safety Analysis | 10.5.1 Safety Analysis For the analysis of safety, the incidence and severity of AEs will be tabulated. Changes from baseline in clinical laboratory variables (including FVIII inhibitor and laboratory parameters for thrombotic potential), vital signs, and physical examination findings will be summarized by descriptive ... | [] |
NCT03734588 | 10.5.2 | Efficacy Analysis | 10.5.2 Efficacy Analysis . Summary statistics will be created by SPK-8016 dose group for the following parameters: - Peak and steady-state FVIII activity levels assessed by coagulation clotting assays. In this study, steady-state levels are based on FVIII:C measurements starting 12 weeks post vector administration and ... | [] |
NCT03734588 | 10.5.3 | Pharmacokinetics Analysis | 10.5.3 Pharmacokinetics Analysis FVIII:C activity level (one stage; central lab-recorded) at nominal weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 following SPK-8016 administration will be summarized descriptively by SPK-8016 dose group. For each participant, the difference between the lab visit date and th... | [] |
NCT03734588 | 10.6 | Exploratory Endpoints Analysis | 10.6 Exploratory Endpoints Analysis All data on the new target joints, joint health score, changes in level of activity, hemophilia activities list, and Haem-A-QoL and EQ-5D-5L questionnaires, as described in [Section 6.2,](#page-73-3) will be summarized descriptively by SPK-8016 dose group and provided in participant ... | [] |
NCT03734588 | 10.7 | Interim Analyses | 10.7 Interim Analyses Interim analyses – may be performed after at least 2 participants from a given dose cohort complete Week 12. The SAP will describe the planned interim analyses in greater detail. | [] |
NCT03734588 | 10.8 | End of Study Definition | 10.8 End of Study Definition A participant is considered to have completed the study if he has completed all phases of the study including the EOS visit in [Table 1.](#page-25-0) The EOS is defined as the date of the last participant's last visit (LPLV).  | [] |
NCT03734588 | 11 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 11 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] |
NCT03734588 | 11.1 | Regulatory, Ethical and Study Oversight Considerations | 11.1 Regulatory, Ethical and Study Oversight Considerations The Sponsor and the Investigator(s) will comply with all instructions, regulations, and agreements in this protocol, and with applicable ICH GCP guidelines, and will conduct the study according to applicable local regulations. The Sponsor and the Investigator(... | [] |
NCT03734588 | 11.1.1 | Regulatory and Ethical Considerations | 11.1.1 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... | [] |
NCT03734588 | 11.1.2 | Financial Disclosure | 11.1.2 Financial Disclosure Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial information as requested to allow the Sponsor to submit complete and accurate financial certification or disclosure statements to the appropriate regulatory authorities. Investigators are respons... | [] |
NCT03734588 | 11.1.3 | Informed Consent Process | 11.1.3 Informed Consent Process - The Investigator or his/her designee will explain the nature of the study to the participant or his legally authorized representative and answer all questions regarding the study. - Participants must be informed that their participation is voluntary. Participants or their legally autho... | [] |
NCT03734588 | 11.1.4 | Data Protection | 11.1.4 Data Protection Prior to any testing under this protocol, including screening tests and assessments, candidates must also provide all authorizations required by local law (e.g., HIPAA authorization in North America). The participant will not be identified by name in the eCRF or in any study reports and these rep... | [] |
NCT03734588 | 11.1.5 | Committee Structure | 11.1.5 Committee Structure The independent DMC is composed of at least 3 independent experts in hemophilia or immunology. The independent DMC will be responsible for reviewing safety and efficacy periodically over the course of the study. The specifics regarding the DMC organization and procedures will be outlined in t... | [] |
NCT03734588 | 11.1.6 | Dissemination of Clinical Study Data | 11.1.6 Dissemination of Clinical Study Data The Sponsor will register the study and post study results, regardless of outcome, on a publicly accessible website (e.g., www.ClinicalTrials.gov), in accordance with the applicable laws and regulations. The Sponsor may also provide study information for inclusion in national... | [] |
NCT03734588 | 11.1.7 | Data Quality Assurance | 11.1.7 Data Quality Assurance - All participant data relating to the study will be recorded using an eCRF unless transmitted to the Sponsor or designee electronically (e.g., laboratory data). The Investigator is responsible for verifying that data entries are accurate and correct by signing the eCRF. - The Investigator... | [] |
NCT03734588 | 11.1.8 | Source Documents | 11.1.8 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 entered in the eCRF that are transcribed from source documents must be consistent with the source documents or ... | [] |
NCT03734588 | 11.1.9 | Study and Site Closure | 11.1.9 Study and Site Closure Study completion is defined as the date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome. A study site is considered closed when all eCRFs have been signed by the Investigator and locked, all required d... | [] |
NCT03734588 | 11.1.10 | Publication Policy | 11.1.10 Publication Policy All study data and intellectual property rights in the results derived from the study are the property of the Sponsor. The Sponsor may utilize the data in various ways, such as submission to government regulatory authorities or disclosure to other Investigators. The Sponsor recognizes that th... | [] |
NCT03734588 | 12 | REFERENCES | 12 REFERENCES - 1. Aledort, L.M., Haschmeyer, R.H., & Pettersson, H. (1994). A longitudinal study of orthopaedic outcomes for severe factor-VIII-deficient haemophiliacs. The Orthopaedic Outcome Study Group. Journal of Internal Medicine, 236(4), 391-9. - 2. Arai, M., Scandella, D., & Hoyer, L.W. (1989). Molecular basis ... | [] |
NCT03734588 | 13 | APPENDIX 1: FACTOR VIII INFUSION LOG | 13 APPENDIX 1: FACTOR VIII INFUSION LOG  - 14 APPENDIX 2: HEMOPHILIA ASSESSMENTS - 14.1 HEMOPHILIA ACTIVITIES LIST               | [] |
NCT03734588 | 14.3 | EQ-5D-5L QUESTIONNAIRE | 14.3 EQ-5D-5L QUESTIONNAIRE      | [] |
NCT03734588 | 14.4 | HEMOPHILIA JOINT HEALTH SCORE | 14.4 HEMOPHILIA JOINT HEALTH SCORE     | [] |
NCT03734588 | 15 | APPENDIX 3: ABBREVIATIONS | 15 APPENDIX 3: ABBREVIATIONS | AAV2 | Adeno-associated virus vector, serotype 2 | |----------|---------------------------------------------------| | AAV5 | Adeno-associated virus vector, serotype 5 | | | | | AAV8 | Adeno-associated virus vector, serotype 8 | | AAVhu37 | Adeno-associated virus vector, serotype hu37 | | ... | [] |
NCT03734588 | 16 | APPENDIX 4: SUMMARY OF CHANGES FROM THE PREVIOUS PROTOCOL VERSION | 16 APPENDIX 4: SUMMARY OF CHANGES FROM THE PREVIOUS PROTOCOL VERSION | AMENDMENT 2SECTION | SUMMARY OF REVISIONS MADE | RATIONALE | |----------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------... | [] |
NCT03791489 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY | [] |
NCT03791489 | 1.1 | SYNOPSIS | 1.1 SYNOPSIS Title: Feasibility Study of Multi-Treatment Posterior Nasal Nerve Modulation for Treatment of Chronic Rhinitis Study Description: Prospective, non-randomized, feasibility study of adult patients for treatment to the posterior nasal nerve using cryotherapy at multiple treatment sites within the nasal cavity... | [
"Secondary Endpoints:",
"Exploratory Endpoints:"
] |
NCT03791489 | 1.2 | SCHEMA | 1.2 SCHEMA  | [] |
NCT03791489 | 1.3 | SCHEDULE OF ACTIVITIES (SOA) | 1.3 SCHEDULE OF ACTIVITIES (SOA) | | Screening (V1)Day -30 to 0 | Baseline (V2)Day -7 to 0 | Treatment (V3)Day 0 | Week Follow-up (V4)Day 7 (±3 days) | 1-Month Follow-up (V5)Day 30 (±7 days) | 3-Month Follow-up (V6)Day 90 (±14 days) | bUnscheduled | |---------------------------------------------------------------------... | [] |
NCT03791489 | 2 | INTRODUCTION | 2 INTRODUCTION | [] |
NCT03791489 | 2.1 | STUDY RATIONALE | 2.1 STUDY RATIONALE Anatomic dissections have demonstrated that parasympathetic nerve fibers innervate the nasal cavity within the inferior meatus as well as the middle meatus. In studies to date (see Section 2.3), interruption of these nerve signals in the middle meatus has demonstrated a response rate of ~80% with re... | [] |
NCT03791489 | 2.2 | BACKGROUND | 2.2 BACKGROUND Rhinitis is a very common condition throughout the world. In the Unites States alone, it affects 10-30% of the adult general population. This accounts for 30-60 million people in the United States and the prevalence has been increasing in recent decades, making it the fifth most common chronic disease in... | [] |
NCT03791489 | 2.3 | REPORT OF PRIOR INVESTIGATIONS | 2.3 REPORT OF PRIOR INVESTIGATIONS
CT-0001 ClariFix Cryoablation Study A pilot clinical study was performed to evaluate the performance of the ClariFix device as a cryosurgical tool to treat subjects with chronic rhinitis. This study was a prospective, multi-center, single-arm interventional study of the ClariFix devi... | [
"CT-0001 ClariFix Cryoablation Study",
"Summary"
] |
NCT03791489 | 2.4 | DEVICE DESCRIPTION | 2.4 DEVICE DESCRIPTION The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis. The ClariFix device (Figure 2) is a handheld cryosurgical device which provides focal, control... | [] |
NCT03791489 | 2.5 | RISK/BENEFIT ASSESSMENT | 2.5 RISK/BENEFIT ASSESSMENT | [] |
NCT03791489 | 2.5.1 | KNOWN POTENTIAL RISKS | 2.5.1 KNOWN POTENTIAL RISKS The study cryotherapy procedure involves transnasal placement of the ClariFix device under endoscopic visualization and use of local anesthesia. In order to minimize risks associated with the study, the procedure will be performed by practicing otolaryngologists experienced in transnasal pro... | [] |
NCT03791489 | 2.5.2 | KNOWN POTENTIAL BENEFITS | 2.5.2 KNOWN POTENTIAL BENEFITS Use of the ClariFix device as a tool during cryosurgery may reduce the symptoms of chronic rhinitis. Improvement in rhinitis symptoms may improve patients' quality of life and may improve work or school productivity. This study may provide valuable information as to the underlying mechani... | [] |
NCT03791489 | 2.5.3 | ASSESSMENT OF POTENTIAL RISKS AND BENEFITS | 2.5.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS Potential risks are typically transient and resolve, however potential improvement in quality of life and symptoms associated with rhinitis have been shown to be durable through at least one-year posttreatment. | [] |
NCT03791489 | 3 | OBJECTIVES AND ENDPOINTS | 3 OBJECTIVES AND ENDPOINTS The study overall objective is to evaluate the feasibility of treatment to the posterior nasal nerve at both the middle and inferior meatus locations within the nasal cavity for improvement in the symptoms of chronic rhinitis. | OBJECTIVES | ENDPOINTS | | | |----------------------------------... | [] |
NCT03791489 | 4 | STUDY DESIGN | 4 STUDY DESIGN | [] |
NCT03791489 | 4.1 | OVERALL DESIGN | 4.1 OVERALL DESIGN Prospective, non-randomized, open-label, multi-center, interventional feasibility study. | [] |
NCT03791489 | 4.2 | END OF STUDY DEFINITION | 4.2 END OF STUDY DEFINITION A subject is considered to have completed the study if he or she has completed all phases of the study including the last visit shown in the Schedule of Activities (SoA), Section 1.3. The end of the study is defined as completion of the last visit shown in the SoA in the trial for all subjec... | [] |
NCT03791489 | 5 | STUDY POPULATION | 5 STUDY POPULATION | [] |
NCT03791489 | 5.1 | INCLUSION CRITERIA | 5.1 INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: - 1. Subject is ≥18 years of age. - 2. Subject has had presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months. - 3. At the Baseline V... | [] |
NCT03791489 | 5.2 | EXCLUSION CRITERIA | 5.2 EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: - 1. Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor. - 2. Subject has had... | [] |
NCT03791489 | 5.3 | SCREEN FAILURES | 5.3 SCREEN FAILURES Screen failures are defined as subjects who consent to participate in the clinical trial but are not subsequently enrolled in the study. A minimal set of screen failure information is required to ensure transparent reporting of screen failure participants. Minimal information includes demography, sc... | [] |
NCT03791489 | 5.4 | STRATEGIES FOR RECRUITMENT AND RETENTION | 5.4 STRATEGIES FOR RECRUITMENT AND RETENTION It is anticipated that up to 5 U.S. based sites will participate in this study. A sufficient number of potential subjects will be screened to be able to complete targeted enrollment of up to thirty (30) subjects within three (3) months of study initiation. Targeted study pop... | [] |
NCT03791489 | 6 | STUDY TREATMENT | 6 STUDY TREATMENT | [] |
NCT03791489 | 6.1 | STUDY TREATMENT ADMINISTRATION | 6.1 STUDY TREATMENT ADMINISTRATION All subjects will receive bilateral cryoablation treatment with the ClariFix device per Instructions for Use (IFU) (See Appendix I). Each side of the nasal cavity will be treated in two locations (see Figure 3): (a) middle meatus and (b) inferior meatus. Each location will receive app... | [] |
NCT03791489 | 6.2 | DEVICE ACQUISITION AND ACCOUNTABILITY | 6.2 DEVICE ACQUISITION AND ACCOUNTABILITY Sponsor will provide the ClariFix devices, at no cost, to be used for the subjects' cryoablation treatments. Devices will be shipped and designated as study-use only. Device usage will be tracked in site's Regulatory documents and individual device lot numbers will be noted in ... | [] |
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