protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05098054 | 9.2.1 | Full Physical Examination | 9.2.1 Full Physical Examination A full physical examination will be performed as outlined in the Schedule of Study Procedures (Section 3.0). Symptom-driven physical examinations may be performed at other times, if deemed necessary by the Investigator or designee. n ions | [] |
NCT05098054 | 9.2.2 | Height and Weight | 9.2.2 Height and Weight Body height (cm) and weight (kg) will be reported as outlined in the Schedule of Study Procedures (Section 3.0). | [] |
NCT05098054 | 9.2.3 | BMI | 9.2.3 BMI BMI will be calculated based on the height and weight measured at screening. m | [] |
NCT05098054 | 9.2.4 | Vital Signs | 9.2.4 Vital Signs Single measurements of temperature, respiratory rate, BP, and PR will be measured as outlined in the Schedule of Study Procedures (Section 3.0). Additional vital signs may be taken at any other times, if deemed necessary. ngle (Secti Blood pressure and pulse rate measurements will be performed with pa... | [] |
NCT05098054 | 9.2.5 | 12-Lead ECG | 9.2.5 12-Lead ECG Single 12-lead ECGs will be performed as outlined in the Schedule of Study Procedures (Section 3.0). Additional ECGs may be taken at any other times, if deemed necessary by the Investigator or designee. Si ECGs will be performed with participants in a supine position (after resting in supine position ... | [] |
NCT05098054 | 9.2.6 | Study Drug Administration | 9.2.6 Study Drug Administration Soticlestat will be provided as described in Section 8.1. The pharmacy at the CRU will provide each dose in individual unit dose containers for each participant, as appropriate. Study drug will be administered with approximately 240 mL of water. Participants will be instructed not to cru... | [] |
NCT05098054 | 9.2.7 | C-SSRS | 9.2.7 C-SSRS Suicidal ideation will be assessed using the C-SSRS at the times stipulated in the Schedule of Study Procedures (Section 3.0). Two versions of the C-SSRS will be used in this study: the Screening/Baseline C-SSRS Lifetime and the Since-Last-Visit C-SSRS. Any suicidal ideation or suicidal behavior during the... | [] |
NCT05098054 | 9.2.8 | AE Monitoring | 9.2.8 AE Monitoring Participants will be monitored throughout the study for adverse reactions to the study drugs and/or procedures as described in Section 10.0. pants | [] |
NCT05098054 | 9.2.9 | Laboratory Procedures and Assessments | 9.2.9 Laboratory Procedures and Assessments All tests listed below will be performed as outlined in the Schedule of Study Procedures (Section 3.0). In addition, laboratory safety tests may be performed at various unscheduled time Study onaddit ts, necessary | [] |
NCT05098054 | 9.2.9.1 | Clinical Laboratory Tests | 9.2.9.1 Clinical Laboratory Tests
Hematology | Hemoglobin | Red blood cell count | | |----------------------------------------|----------------------|--| | Hematocrit | Platelet count | | | Total and differential leukocyte count | | |
Coagulation | Activated partial thromboplastin time | PT/ INR | |------------------... | [
"Hematology",
"Coagulation",
"Chemistry",
"Urinalysis"
] |
NCT05098054 | 9.2.9.1.1 | Other | 9.2.9.1.1 Other | HIV test | | | Urine/saliva drug screen | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------|----------------------------------------------------... | [] |
NCT05098054 | 9.3 | PK Samples | 9.3 PK Samples Table 9.a Primary Specimen Collections | Specimen Name | PrimarySpecimen | PrimarySpecimenDerivative | Description of Intended Use | SampleCollection | |----------------------|---------------------|-----------------------------------|-------------------------------|----------------------| | Plasma sample... | [] |
NCT05098054 | 9.3.1 | PK Measurements | 9.3.1 PK Measurements Pharmacokinetic parameters of soticlestat will be calculated from the individual concentration-time profiles from all evaluable participants using noncompartmental analysis methods. Actual sampling times, rather than scheduled sampling times, will be used in all computations involving sampling tim... | [
"CONFIDENTIAL"
] |
NCT05098054 | 9.3.1.1 | Plasma for PK Measurements | 9.3.1.1 Plasma for PK Measurements The following PK parameters will be calculated from plasma concentrations of sotisclestat unless otherwise specified: AUClast: The area under the concentration-time curve, from time 0 to the last quantifiable concentration, as calculated by the linear-log trapezoidal g extrapol method... | [] |
NCT05098054 | 9.3.2 | Biomarker Measurements | 9.3.2 Biomarker Measurements Not applicable. | [] |
NCT05098054 | 9.3.3 | PGx Measurements | 9.3.3 PGx Measurements Not applicable. | [] |
NCT05098054 | 9.3.4 | Confinement | 9.3.4 Confinement Participants will be restricted and confined to the CRU on Day -1, at the time indicated by the CRU, until after the 144-hour blood draw and/or study procedures (Day 7) as outlined in the Schedule of Study Procedures (Section 3.0). Participants may be admitted to the CRU earlier for COVID-19 procedure... | [] |
NCT05098054 | 10.0 | ADVERSE EVENTS | 10.0 ADVERSE EVENTS | [] |
NCT05098054 | 10.1 | Definitions and Elements of AEs | 10.1 Definitions and Elements of AEs An AE is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. s invest An AE can therefore be any unfavorable and u... | [
"Laboratory values and ECG findings:",
"Pre-existing conditions:",
"Worsening of AEs:",
"Changes in severity of AEs: severit",
"Preplanned surgeries or procedures:",
"Elective surgeries or procedures:",
"Overdose:"
] |
NCT05098054 | 10.1.1 | SAEs | 10.1.1 SAEs An SAE is defined as any untoward medical occurrence that at any dose: any - 1. Results in DEATH. - 2. Is LIFE THREATENING. - The term "life threatening" refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event that hypothetically might have ca... | [] |
NCT05098054 | 10.1.2 | Special Interest AEs | 10.1.2 Special Interest AEs | [] |
NCT05098054 | 10.2 | AE Procedures | 10.2 AE Procedures | [] |
NCT05098054 | 10.2.1 | Assigning Severity/Intensity of AEs | 10.2.1 Assigning Severity/Intensity of AEs Moderate: An adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe: An ad... | [] |
NCT05098054 | 10.2.2 | Assigning Causality of AEs | 10.2.2 Assigning Causality of AEs The relationship of each AE to study medication(s) will be assessed using the following categories: ies on.on(s) follo Related: An AE that follows a reasonable temporal sequence from administration of a ws drug (including the course after withdrawal of the drug), or for which a causal ... | [] |
NCT05098054 | 10.2.3 | Start Date | 10.2.3 Start Date The start date of the AE is the date that the first signs/symptoms were noted by the participant and/or Investigator. n | [] |
NCT05098054 | 10.2.4 | End Date | 10.2.4 End Date The end date of the AE is the date at which the participant recovered, the event resolved but with sequelae or the participant died. | [] |
NCT05098054 | 10.2.5 | Pattern of Adverse Event (Frequency) | 10.2.5 Pattern of Adverse Event (Frequency) Episodic AEs (eg, headache) or those which occur repeatedly over a period of consecutive days are intermittent. All other events are continuous or single episodes. ermittent. o | [] |
NCT05098054 | 10.2.6 | Action Taken With Study Treatment | 10.2.6 Action Taken With Study Treatment - Drug withdrawn a study medication is stopped due to the particular AE. - Dose not changed the particular AE did not require stopping a study medication. - Unknown only to be used if it has not been possible to determine what action has been taken. - Not applicable a study medi... | [] |
NCT05098054 | 10.2.7 | Outcome | 10.2.7 Outcome - Recovered/resolved participant returned to first assessment status with respect to the AE. - Recovering/resolving the intensity is lowered by one or more stages: the diagnosis has or signs/symptoms have almost disappeared; the abnormal laboratory value improved, but has not returned to the normal range... | [] |
NCT05098054 | 10.2.8 | Collection and Reporting of AEs, SAEs, and Abnormal LFTs ion | 10.2.8 Collection and Reporting of AEs, SAEs, and Abnormal LFTs ion | [] |
NCT05098054 | 10.2.8.1 | Collection Period | 10.2.8.1 Collection Period Collection of AEs (ie, AEs, SAEs, and Abnormal LFTs) will commence at the time the participant signs the informed consent. Routine collection of AEs will continue until the follow-up phone call on Day 14 ± 2 days after the soticlestat dose. For participants who discontinue prior to the admini... | [] |
NCT05098054 | 10.2.8.2 | Reporting AEs | 10.2.8.2 Reporting AEs At each study visit, the Investigator will assess whether any subjective AEs have occurred. A neutral question, such as "How have you been feeling since your last visit?" may be asked. Participants may report AEs occurring at any other time during the study. Participants experiencing an SAE prior... | [] |
NCT05098054 | 10.2.8.3 | Reporting SAEs | 10.2.8.3 Reporting SAEs When an SAE occurs through the AE collection period it should be reported according to the procedure outlined below: A Takeda SAE form must be completed, in English and signed by the Investigator immediately or within 24 hours of first onset or notification of the event. The information should b... | [] |
NCT05098054 | 10.2.8.3.1 | SAE Follow-Up | 10.2.8.3.1 SAE Follow-Up If information is not available at the time of the first report becomes available at a later date, the Investigator should complete a follow-up SAE form or provide other written documentation and fax it immediately within 24 hours of receipt. Copies of any relevant data from the hospital notes ... | [
"Healthy Participants Only"
] |
NCT05098054 | 10.2.9 | Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities | 10.2.9 Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities The Sponsor will be responsible for reporting all suspected unexpected serious adverse reactions (SUSARs) and any other applicable SAEs to regulatory authorities, Investigators and IRBs or IECs, as applicable, in accordance with national... | [] |
NCT05098054 | 11.0 | STATISTICAL METHODS | 11.0 STATISTICAL METHODS | [] |
NCT05098054 | 11.1 | Statistical and Analytical Plans | 11.1 Statistical and Analytical Plans Detailed methodology for summary and statistical analyses of the data collected in this study will be documented in a SAP. The SAP will be prepared by Celerion and agreed upon with the Sponsor. This document may modify the plans outlined in the protocol; however, any major modifica... | [] |
NCT05098054 | 11.1.1 | Analysis Sets | 11.1.1 Analysis Sets | [] |
NCT05098054 | 11.1.1.1 | PK Set | 11.1.1.1 PK Set All participants who comply sufficiently with the protocol and display an evaluable PK profile (eg, exposure to treatment, availability of measurements and absence of major protocol violations) will be included in the statistical analyses. he f o | [] |
NCT05098054 | 11.1.1.2 | Safety Set | 11.1.1.2 Safety Set All participants who received the dose of soticlestat will be included in the safety evaluations. safet | [] |
NCT05098054 | 11.1.1.3 | PD Set | 11.1.1.3 PD Set Not applicable. | [] |
NCT05098054 | 11.1.2 | Analysis of Demography and Other Baseline Characteristics | 11.1.2 Analysis of Demography and Other Baseline Characteristics Continuous demographic data (ie, age, weight, height, and BMI) will be listed and summarized using appropriate summary statistics. Categorical demographic data (ie, sex, race, and ethnicity) will also be listed and tabulated. statist | [] |
NCT05098054 | 11.1.3 | PK Analysis | 11.1.3 PK Analysis Statistical analysis of PK data will be based on the PK analysis set. an Descriptive statistics will be used to summarize concentrations of soticlestat and PK parameters according to hepatic function group (normal hepatic function, moderate and mild HI). An ANOVA will be performed on the ln-transform... | [] |
NCT05098054 | 11.1.4 | PD Analysis | 11.1.4 PD Analysis Not applicable. | [] |
NCT05098054 | 11.1.5 | Safety Analysis | 11.1.5 Safety Analysis All safety data will be populated in the individual CRFs. Dosing dates and times will be listed by participant. TEAEs will be tabulated. The remaining quantitative safety data as well as the difference to baseline, when appropriate, will be summarized using the appropriate descriptive statistics.... | [] |
NCT05098054 | 11.1.5.1 | AEs | 11.1.5.1 AEs AEs will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) available at Celerion and summarized by group for the number of participants reporting the TEAE and the number of TEAEs reported. A by-participant AE data listing including verbatim term, coded term, ... | [] |
NCT05098054 | 11.1.5.2 | Clinical Laboratory | 11.1.5.2 Clinical Laboratory Clinical laboratory results will be summarized by group and point of time of collection and a shift table describing out of normal range shifts will be provided. ts e teria laboratory MAV criteria for safety laboratory assessments will be defined in the SAP. | [] |
NCT05098054 | 11.1.5.3 | Vital Signs | 11.1.5.3 Vital Signs Vital signs assessments will be summarized by group and point of time of collection and a shift table describing out of normal range shifts will be provided. by e provided MAV criteria for vital signs will be defined in the SAP. vi | [] |
NCT05098054 | 11.1.5.4 | Other Safety Parameters | 11.1.5.4 Other Safety Parameters Physical examination findings will be presented in the data listings. examinat ECGs and C-SSRS results will be summarized by group and point of time of collection and a shift table describing out of normal range shifts will be provided. MAV criteria for ECGs will be defined in the SAP. ... | [] |
NCT05098054 | 11.2 | Interim Analysis and Criteria for Early Termination | 11.2 Interim Analysis and Criteria for Early Termination After all participants in the moderate HI arm and 12 participants in the matched normal hepatic function arm are enrolled, an informal interim PK data analysis is planned and may additionally leverage historical control PK data in healthy participants to gain an ... | [] |
NCT05098054 | 11.3 | Determination of Sample Size | 11.3 Determination of Sample Size The planned sample size of 8 participants in each HI arm is not based on power calculations and is considered adequate to provide a descriptive characterization of the PK of soticlestat in participants with moderate or mild HI compared to healthy participants with normal hepatic functi... | [] |
NCT05098054 | 12.0 | QUALITY CONTROL AND QUALITY ASSURANCE | 12.0 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT05098054 | 12.1 | Study-Site Monitoring Visits Site | 12.1 Study-Site Monitoring Visits Site Monitoring visits to the study sites will be made periodically during the study to ensure that all aspects of the protocol are followed. Detailed information for monitoring visits to be conducted in this study will be documented in a Clinical Research Associate Monitoring Plan and... | [] |
NCT05098054 | 12.2 | Protocol Deviations | 12.2 Protocol Deviations The Investigator should not deviate from the protocol, except where necessary to eliminate an immediate hazard to study participants. Should other unexpected circumstances arise that will require deviation from protocol-specified procedures, the Investigator should consult with the sponsor or d... | [] |
NCT05098054 | 12.3 | Quality Assurance Audits and Regulatory Agency Inspections ality | 12.3 Quality Assurance Audits and Regulatory Agency Inspections ality The study site also may be participant to quality assurance audits by the Sponsor or designees. In this circumstance, the Sponsor-designated auditor will contact the site in advance to arrange an auditing visit. The auditor may ask to visit the facil... | [] |
NCT05098054 | 13.0 | ETHICAL ASPECTS OF THE STUDY | 13.0 ETHICAL ASPECTS OF THE STUDY This study will be conducted with the highest respect for the individual participants (ie, participants) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the International Council on Harmonisation (ICH) Harmonised Tripartite G... | [] |
NCT05098054 | 13.1 | IRB and/or IEC Approval | 13.1 IRB and/or IEC Approval IRBs and IECs must be constituted according to the applicable state and federal/local requirements of each participating region. The Sponsor or designee will require documentation noting all names and titles of members who make up the respective IRB or IEC. If any member of the IRB or IEC h... | [] |
NCT05098054 | 13.2 | Participant Information, Informed Consent, and Participant Authorization | 13.2 Participant Information, Informed Consent, and Participant Authorization Written consent documents will embody the elements of informed consent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations. The ICF, participant authori... | [] |
NCT05098054 | 13.3 | Participant Confidentiality | 13.3 Participant Confidentiality The Sponsor and designees affirm and uphold the principle of the participant's right to protection against invasion of privacy. Throughout this study, a participant's source data will only be linked to the Sponsor's clinical study database or documentation via a unique identification nu... | [] |
NCT05098054 | 13.4 | Publication, Disclosure, and Clinical Study Registration Policy | 13.4 Publication, Disclosure, and Clinical Study Registration Policy | [] |
NCT05098054 | 13.4.1 | Publication and Disclosure | 13.4.1 Publication and Disclosure The Investigator is obliged to provide the Sponsor with complete test results and all data derived by the Investigator from the study. During and after the study, only the Sponsor may make study information available to other study Investigators or to regulatory agencies, except as req... | [] |
NCT05098054 | 13.4.2 | Clinical Study Registration | 13.4.2 Clinical Study Registration In order to ensure that information on clinical trials reaches the public in a timely manner and to comply with applicable laws, regulations and guidance, Takeda will, at a minimum register all interventional clinical trials it Sponsors anywhere in the world on ClinicalTrials.gov and/... | [] |
NCT05098054 | 13.4.3 | Clinical Study Results Disclosure | 13.4.3 Clinical Study Results Disclosure Takeda will post the results of clinical studies on ClinicalTrials.gov or other publicly accessible websites, as required by Takeda Policy/Standard, applicable laws and/or regulations. | [] |
NCT05098054 | 13.5 | Insurance and Compensation for Injury | 13.5 Insurance and Compensation for Injury Each participant in the study must be insured in accordance with the regulations applicable to the site where the participant is participating. If a local underwriter is required, then the Sponsor or Sponsor's designee will obtain clinical study insurance against the risk of i... | [] |
NCT05098054 | 14.0 | ADMINISTRATIVE AND REFERENCE INFORMATION | 14.0 ADMINISTRATIVE AND REFERENCE INFORMATION | [] |
NCT05098054 | 14.1 | Administrative Information | 14.1 Administrative Information | [] |
NCT05098054 | 14.1.1 | Study Contact Information | 14.1.1 Study Contact Information | Contact Type / Role | Contact | |-----------------------------------------------|-------------------| | Serious adverse event and pregnancy reporting | Pharmacovigilance |
INVESTIGATOR AGREEMENT confirm that have read and that I understand this protocol, the Investigator's Brochure, ... | [
"INVESTIGATOR AGREEMENT",
"INVESTIGATOR AGREEMENT"
] |
NCT05098054 | 14.1.3 | Study-Related Responsibilities | 14.1.3 Study-Related Responsibilities | [] |
NCT05098054 | 14.1.4 | List of Abbreviations | 14.1.4 List of Abbreviations | 14.1.3 | UseStudy-Related Responsibilities | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05098054 | 15.0 | DATA HANDLING AND RECORDKEEPING | 15.0 DATA HANDLING AND RECORDKEEPING The full details of procedures for data handling will be documented in the Data Management Plan. AEs, medical history, and concurrent conditions will be coded using the MedDRA®. Drugs will be coded using the WHO Drug Dictionary. | [] |
NCT05098054 | 15.1 | CRFs (Electronic and Paper) | 15.1 CRFs (Electronic and Paper) Completed CRFs are required for each participant who signs an informed consent. The Sponsor or its designee will supply investigative sites with access to CRFs. The Sponsor will make arrangements to train appropriate site staff in the use of the CRF. These forms are used to transmit the... | [] |
NCT05098054 | 15.2 | Record Retention | 15.2 Record Retention The Investigator agrees to keep the records stipulated in Section 15.1 and those documents that include (but are not limited to) the study-specific documents, the identification log of all participating participants, medical records, temporary media such as thermal sensitive paper, source workshee... | [] |
NCT05098054 | 16.0 | REFERENCES | 16.0 REFERENCES - 1. TAK-935. Takeda Pharmaceutical Company Ltd. Global Investigator's Brochure. Edition 7, 31 January 2022; plus Addendum 1, 03 February 2022, for Edition 7, 31 January 2022. Edi - 2. Rodighiero V. Effects of liver disease on pharmacokinetics. An update. Clin Pharmacokinet 1999;37(5):399-431. ghiero - ... | [] |
NCT05098054 | 17.0 | APPENDICES | 17.0 APPENDICES
Appendix A Responsibilities of the Investigator Clinical research studies sponsored by the Sponsor are subject to ICH GCP and all the applicable local laws and regulations. The responsibilities imposed on investigators by the FDA are summarized in the "Statement of Investigator" (Form FDA 1572), which ... | [
"Appendix A Responsibilities of the Investigator",
"Appendix B Elements of the Participant Informed Consent",
"Appendix C Investigator Consent to the Use of Personal Information",
"Appendix D Pregnancy and Contraception Contraception and Pregnancy Avoidance Procedure",
"Hormonal Methods:",
"CONFIDENTIAL",... |
NCT05126563 | 1 | Ethics and Regulatory Compliance Statement | 1 Ethics and Regulatory Compliance Statement 2 - 3 The procedures outlined in this protocol are designed to ensure that the Hope Biosciences Stem - 4 Cell Research Foundation, and principal investigator(s) abide by the International Conference on Harmonization (ICH) current Good Clinical Practice (cGCP) guidelines, cur... | [
"Study Summary",
"Objectives",
"Primary Objectives",
"Secondary Objectives",
"Endpoints",
"Primary Endpoints",
"Secondary Endpoints",
"Investigational Plan.",
"Withdrawal Criteria",
"Selection of Clinical Trial Population",
"Clinical Trial Population",
"Eligibility Criteria",
"Inclusion Crit... |
NCT05130762 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY | [] |
NCT05130762 | 1.1 | Synopsis | 1.1 Synopsis | Protocol Title | A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™Disinfecting Cap Use on Needle-Free Connectors | | | | | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------... | [
"Schema"
] |
NCT05130762 | 2 | INTRODUCTION | 2 INTRODUCTION | [] |
NCT05130762 | 2.1 | Background | 2.1 Background Catheter-related blood stream infections (CRBSI) are bacterial infections that originate within a vascular access device (VAD). The International Society for Infectious Diseases report that CRBSIs account for 11% of all healthcare-associated infections and have an estimated attributable mortality rate be... | [] |
NCT05130762 | 2.2 | Rationale | 2.2 Rationale This study is designed to provide data utilizing the BD PureHub™ Disinfecting Cap for the purpose of providing clinical data required under EU regulation 2017/745. | [] |
NCT05130762 | 2.3 | Risk/Benefit Assessment | 2.3 Risk/Benefit Assessment The BD PureHub™ Disinfecting Cap has been on the market in Europe since 2018 and as of July 2020, PureHub™ has been used in 122 institutions in EU and 131 institutions in US with more than 21.9 million units sold. More detailed information about the known and expected benefits and risks and ... | [] |
NCT05130762 | 2.3.1 | Risk Assessment | 2.3.1 Risk Assessment Potential risks for the BD PureHub™ Disinfecting Cap devices are based on items noted in the Instructions for Use and are not unique to this study. Protocol Number: MDS-20PUREU001 CONFIDENTIAL | Version: 2.5 PMCF – AT01 | Date: 01DEC2022 | |--------------------------|-----------------| | | | | Pot... | [] |
NCT05130762 | 2.3.2 | Benefit Assessment | 2.3.2 Benefit Assessment There is no direct benefit for study participation for an individual patient, however the clinical benefits for the BD PureHub™ Disinfecting Cap are as follows: - a. Easy to use disinfecting device for needle-free connectors. - b. Easy to use device to act as a physical barrier on needle-free c... | [] |
NCT05130762 | 2.3.3 | Overall Benefit: Risk Conclusion | 2.3.3 Overall Benefit: Risk Conclusion The BD PureHubTM Disinfecting Cap will be used by trained individuals as intended as part of this study on any patient population with consideration given to the procedure being performed and the disease state of the patient. There is no anticipated additional risk associated with... | [] |
NCT05130762 | 3 | OBJECTIVES AND ENDPOINTS | 3 OBJECTIVES AND ENDPOINTS | Objectives | Endpoints | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------... | [] |
NCT05130762 | 4 | STUDY DESIGN | 4 STUDY DESIGN | [] |
NCT05130762 | 4.1 | Overall Design | 4.1 Overall Design This is a multi-center, single-arm, prospective post-market study that will enroll up to 175 participants in order to have 150 evaluable participants who have vascular access devices as part of their routine medical care. Data related to the safety and performance of the BD PureHub™ Disinfecting Cap ... | [] |
NCT05130762 | 4.2 | Scientific Rationale for Study Design | 4.2 Scientific Rationale for Study Design This study is designed to collect clinical data on the performance of the BD PureHub™ Disinfecting Cap. The usage of the BD PureHub™ Disinfecting Cap according to its intended use will ensure that study activities have no direct impact on the endpoints being assessed and that t... | [] |
NCT05130762 | 4.2.1 | Participant Input into Design | 4.2.1 Participant Input into Design Not applicable. | [] |
NCT05130762 | 4.3 | End of Study Definition | 4.3 End of Study Definition A participant is considered to have completed the study when one of the following conditions are met, whichever is the earliest.: - upon one week post VAD therapy (after the last VAD is removed), - at department discharge provided the clinical investigation team cannot follow-up the particip... | [] |
NCT05130762 | 5 | STUDY POPULATION | 5 STUDY POPULATION | [] |
NCT05130762 | 5.1 | Inclusion Criteria | 5.1 Inclusion Criteria In order to be eligible to participate in this study, an individual of any age or gender, must meet all of the following criteria: - 1. Has an eligible vascular access device in situ or will have one placed with needle-free connectors - Note: This covers all needle-free devices, including central... | [] |
NCT05130762 | 5.2 | Exclusion Criteria | 5.2 Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: - 1. BD PureHub™ Disinfecting Cap or any other disinfecting cap in place for more than twelve (12) hours (>12 hours) prior to study participation - 2. Presence of any infection, bacteremia, or septicemia is known or ... | [] |
NCT05130762 | 5.3 | Lifestyle Considerations | 5.3 Lifestyle Considerations Not applicable. | [] |
NCT05130762 | 5.4 | Screen Failures | 5.4 Screen Failures Screen failures are not anticipated due to the non-investigational nature of the study. | [] |
NCT05130762 | 5.5 | Vulnerable Population | 5.5 Vulnerable Population As the instruction for use of the BD PureHub™ Disinfecting Caps does not foresee any limitations in terms of subject age or status and the study aims to collect data on clinical use, the study will also consider participants under 18 years of age, or participants requiring a LAR. In addition, ... | [] |
NCT05130762 | 6 | STUDY INTERVENTION | 6 STUDY INTERVENTION | [] |
NCT05130762 | 6.1 | Investigational/Test Device | 6.1 Investigational/Test Device BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting device for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. It is comprised of a threaded plastic cap containing a porous pad pre-saturated with 70% IPA, a... | [] |
NCT05130762 | 6.2 | Control Device/Standard of Care | 6.2 Control Device/Standard of Care Not applicable; this is a single-arm study. | [] |
NCT05130762 | 6.3 | Ancillary Devices/Products | 6.3 Ancillary Devices/Products Ancillary devices will include the participant's VAD, eligible needle-free luer connectors, intravenous tubing, and dressings, or any other material associated with the participant venous access. These products will be used as part of the standard of care of each site. Selected informatio... | [] |
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