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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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Pediatric New Enrollment


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General
Study Status Study Pending
Application Number P170039 / PAS002
Date Current Protocol Accepted  
Study Name Pediatric New Enrollment
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 Design Description 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 Description 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.
Data Collection 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


Pediatric New Enrollment Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/28/2018 12/27/2018 Overdue/Received
one year report 05/30/2019 05/30/2019 On Time
18 month report 11/28/2019   Overdue
two year report 05/29/2020    
three year report 05/29/2021    
four year report 05/29/2022    
five year report 05/29/2023    


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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