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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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Pediatric New Enrollment


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General
Study Status Delayed
Application Number /
Requirement Number		 P170039 / PAS002
Date Original Protocol Accepted 10/03/2019
Date Current Protocol Accepted  
Study Name Pediatric New Enrollment
Device Name CustomFlex Artificial Iris
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives Prospective, non-masked, multicenter study to determine the long-term (60 months) safety and effectiveness of the CustomFlex™ Artificial Iris for the treatment of full or partial iris defects in pediatric subjects.
The study will include follow-up data for up to 5 years from previously enrolled pediatric subjects who participated in the 12-month AI-001 IDE study and are participating in the AI-001 extended follow-up PAS (P170039/S001). In addition, this study will include additional newly enrolled pediatric subjects.
Study Population The study includes the implanted subjects. There is no control arm. The postoperative outcomes are compared to their preoperative baseline.
Sample Size The Pediatric New Enrollment Cohort will include enrollment of up to 125 additional pediatric eyes (depending on how many pediatric eyes are enrolled in the ODE led PAS), meeting all of the inclusion and exclusion criteria below, to provide a total of 125 treated pediatric eyes when the Pediatric New Enrollment Cohort is combined with the Pediatric Rollover Cohort. Treating a total of up to 125 pediatric eyes will ensure that ~100 pediatric eyes will be available for assessment at 5 years postoperatively.
Key Study Endpoints The primary study outcome is to evaluate device related adverse events (AEs) postoperatively at Month 60.
The secondary study outcome is to evaluate the cumulative rate of intraocular lens (IOL)-related AEs at Month 60.
Other outcomes:
Secondary surgical interventions, implant position, device or surgery related complications, and device malfunctions or defects. Outcomes that will be evaluated include, but are not limited to:
Cumulative AEs
Endothelial cell density (ECD) changes
Device malfunction or defects
Device related complications
Follow-up Visits and Length of Follow-up 60 months
Interim or Final Data Summary
Actual Number of Patients Enrolled 0
Actual Number of Sites Enrolled 4


Pediatric New Enrollment Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/28/2018 12/27/2018 Overdue/Received
1 year report 05/30/2019 05/30/2019 On Time
18 month report 11/28/2019 01/30/2020 Overdue/Received
2 year report 05/29/2020 05/28/2020 On Time
3 year report 05/29/2021 06/01/2021 Overdue/Received
4 year report 05/29/2022 06/02/2022 Overdue/Received
5 year report 05/29/2023 06/01/2023 Overdue/Received
66 month report 09/01/2023 09/13/2023 Overdue/Received
6 year report 05/29/2024    


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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