f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Flourish Real-World Evidence PAS


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General
Study Status Delayed
Application Number /
Requirement Number		 H150003 / PAS002
Date Original Protocol Accepted 10/02/2020
Date Current Protocol Accepted  
Study Name Flourish Real-World Evidence PAS
Device Name Flourish Pediatric Esophageal Atresia Anastomosis Device
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Objectives Objective: Continued evaluation of safety and probable benefit after approval of the Flourish device

Design: A single-arm, RWE observational study with both prospective and retrospective data collection from patients’ medical records.
Study Population Patients meeting the following criteria are eligible for participation in the study:
1. Has esophageal atresia (EA)
2. Atretic gap < 4cm
3. Absence of, or repaired tracheoesophageal fistula (TEF)
4. Less than 1 year of age
5. Absence of visible teeth
6. Gastrostomy tract properly sized to accommodate an 18 Fr gastric catheter
7. Absence of gastrostomy site signs of significant infection (significant as determined by physician)
8. Parent or guardian of patient provides informed consent for use of data

There is no comparator group in this study.
Sample Size A minimum of 20 patients will be enrolled.
Key Study Endpoints Primary outcome measures for continued evaluation of device safety are rates of the following:
• Stricture at the anastomotic site leading to the need for dilation or surgery
• Peri-anastomotic leaks
• Other adverse events and/or complications possibly, probably, or causally related to the device or procedure

The secondary outcome measure for evaluation of probable benefit is successful anastomosis formation, which is defined as creation of a lumen connecting the upper esophageal pouch to the lower esophageal pouch. Per the IFU, successful anastomosis formation is confirmed by showing connected flow of contrast agent.
Follow-up Visits and Length of Follow-up 2 years after Flourish treatment

There are no prespecified follow-up visits for this study, as patients will be cared for according to the physician’s clinical judgment. Data will be extracted from the medical record through 24 months and will be allocated into intervals of 2 weeks, and 1, 3, 6, 12, 18, and 24 months or until study exit.
Interim or Final Data Summary
Actual Number of Patients Enrolled 21
Actual Number of Sites Enrolled 12
Patient Follow-up Rate N/A


Flourish Real-World Evidence PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/02/2021 04/01/2021 On Time
1 year report 10/02/2021 10/04/2021 Overdue/Received
18 month report 04/02/2022 04/01/2022 On Time
2 year report 10/02/2022 09/28/2022 On Time
30 month report 04/02/2023 03/30/2023 On Time
3 year report 10/02/2023 09/28/2023 On Time
final report 02/29/2024 02/29/2024 On Time


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

Additional Resources

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