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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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NOVEL/NOVEL Ext Cont Long Term PAS


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General
Study Status Progress Adequate
Application Number P180014 / PAS001
Date Current Protocol Accepted  
Study Name NOVEL/NOVEL Ext Cont Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent & Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the XVIVO Registry is to collect standard of care clinical data from all comers who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device and monitor device-related serious adverse events. At the same time, a continuation study for the study subjects previously enrolled in the NOVEL and NOVEL Extension studies will be conducted to continue to capture long-term data on patients transplanted with donor lungs treated with the XPS System. These are single arm studies and the collected data will be compared to UNOS data on survival and primary graft dysfunction (PGD) at 72 hours post-transplantation, Bronchiolitis Obliterans Syndrome (BOS), FEV1, functional status and survival at 1, 2, 3, 4, and 5 years. The comparator data will be collected for all patients transplanted during the same time frame and from the same sites as the XVIVO Registry patients.
Study Population Description All comers (all patients receiving donor lungs treated with the XPS System)
Sample Size All comers

Primary Effectiveness Endpoint:

Co-primary endpoints to be compared to control data:

Survival at 1 year post-transplantation;

Rate of Grade 3 PGD at 72 hours post-transplantation.

Secondary Effectiveness Endpoints:

Survival at 2, 3, 4, and 5 years post-transplantation for registry and control patients;

FEV1 at 1, 2, 3, 4, and 5 years post-transplantation per UNOS data collection (obtained from routine pulmonary function test performed closest to their anniversary);

Incidence of Bronchiolitis Obliterans Syndrome (BOS) at 1, 2, 3, 4, and 5 years post-transplantation;

Number of hospitalizations from transplant to 1, 2, 3, 4, and 5 years post-transplantation;

Number of rejection episodes from transplant to 1, 2, 3, 4, and 5 years post-transplantation;

Quality of life at 1, 2, 3, 4, and 5 years post-transplantation:

Functional status;

Physical capacity;

Employment limitations.
Data Collection Device-related serious adverse events from transplantation through 30 days post-transplantation, or initial hospital stay, whichever is longer.

Co-primary endpoints to be compared to control data:

Survival at 1 year post-transplantation;

Rate of Grade 3 PGD at 72 hours post-transplantation.

Secondary Effectiveness Endpoints

Survival at 2, 3, 4, and 5 years post-transplantation for registry and control patients;

FEV1 at 1, 2, 3, 4, and 5 years post-transplantation per UNOS data collection (obtained from routine pulmonary function test performed closest to their anniversary);

Incidence of Bronchiolitis Obliterans Syndrome (BOS) at 1, 2, 3, 4, and 5 years post-transplantation;

Number of hospitalizations from transplant to 1, 2, 3, 4, and 5 years post-transplantation;

Number of rejection episodes from transplant to 1, 2, 3, 4, and 5 years post-transplantation;

Quality of life at 1, 2, 3, 4, and 5 years post-transplantation:

Functional status;

Physical capacity.
Follow-up Visits and Length of Follow-up 5 years


NOVEL/NOVEL Ext Cont Long Term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/25/2019 11/14/2019 Overdue/Received
one year report 04/25/2020 06/03/2020 Overdue/Received
18 month report 10/24/2020    
two year report 04/25/2021    
three year report 04/25/2022    
four year report 04/25/2023    
five year report 04/24/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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