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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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Flourish Post-Approval Study


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General
Study Status Progress Adequate
Application Number H150003 / PAS001
Date Current Protocol Accepted  
Study Name Flourish Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Design Description Study Objective and Design Objective: continued evaluation of safety and probable benefit
post-approval of the Flourish device.

Design: a prospective, single-arm, observational clinical study. It is a new enrollment study.
Study Population Description A patient is suitable for participation in the study if the patient meets the following criteria:

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

No comparator group.

Sample Size A minimum of 20 patients will be enrolled
Data Collection The primary outcome measures for continued evaluation of device safety are the 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. This 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


Flourish Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/10/2017 11/27/2017 Overdue/Received
one year report 05/12/2018 05/15/2018 Overdue/Received
18 month report 11/10/2018 11/09/2018 On Time
two year report 05/12/2019    
three year report 05/11/2020    
four year report 05/11/2021    
Final Report 02/01/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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