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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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TOP PAS Registry


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General
Study Status Progress Inadequate
Application Number P160013 / PAS002
Date Current Protocol Accepted  
Study Name TOP PAS Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a single-arm, prospective, multi-center post-approval U.S. registry study on double lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System. This all-comers registry is designed to evaluate short- and long-term safety and effectiveness of the OCS™ Lung System for lung transplantation in a real-world setting.
Study Population Description This is a single-arm study on double lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System.
Sample Size The PAS will include a minimum of 500 double lung transplant recipients transplanted with donor lungs preserved using the OCS™ Lung System.

Data Collection Primary Safety Endpoint The number of lung graft-related serious adverse events (SAEs) through 30 days post-transplant or through initial transplant surgical admission if longer than 30 days, per subject, consisting of the following SAEs (at most one per type):

• Respiratory failure requiring prolonged intubation beyond 4 days or reintubation

• Bronchial anastomotic complications

• Major pulmonary-related infection

Secondary Safety Endpoints 3. Survival incidence (simple proportion) at 30 days.

4. Survival incidence (simple proportion) at initial transplant surgery hospital discharge, if longer than 30 days.

Primary Effectiveness Endpoint 12-month patient and graft survival post transplantation with the OCS™ Lung System, i.e. double-lung transplant

Secondary Effectiveness Endpoints 1) Total ischemic time for OCS™-preserved lungs

2) Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)

3) Incidence of PGD3 at T72 hours

4) Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs

5) Kaplan-Meier survival estimated at Month 1, 6, 12, 24, 36, 48 and 60

6) Survival incidence (simple proportion) at Month 6, 12, 24, 36, 48 and 60

7) Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60

8) Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60

9) Incidence of BOS at Month 12, 24, 36, 48 and 60 (BOS grading will be collected)

10) Incidence of re-transplantation (graft failure) at Month 12, 24, 36, 48 and 60

11) Kaplan-Meier transplantation-free survival estimated at Month 12, 24, 36, 48 and 60

Other Endpoints 1) Incidence of PGD3 at T72 hours.

2) Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs.

3) Kaplan-Meier survival estimated at Month 1, 6, 12, 24, 36, 48, and 60.

4) Survival incidence (simple proportion) at Month 1, 6, 12, 24, 36, 48, and 60.

5) BOS-free survival (freedom from BOS and mortality) using Kaplan-Meier survival estimated at Month 12, 24, 36, 48, and 60.

6) Freedom from BOS using Kaplan-Meier survival estimated at Month 12, 24, 36, 48, and 60.

7) Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 12, 24, 36, 48, and 60 (BOS grading will be collected).

8) Incidence of re-transplantation (graft failure) at Month 12, 24, 36, 48, and 60.

Follow-up Visits and Length of Follow-up 5 years


TOP PAS Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/20/2018 09/21/2018 Overdue/Received
one year report 03/22/2019 03/22/2019 On Time
18 month report 09/20/2019    
two year report 03/21/2020    
three year report 03/21/2021    
four year report 03/21/2022    


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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