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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Continued Follow-Up of G170301 Clinical Study


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General
Study Status Ongoing
Application Number /
Requirement Number
P200036 / PAS001
Date Original Protocol Accepted 03/01/2022
Date Current Protocol Accepted 07/15/2022
Study Name Continued Follow-Up of G170301 Clinical Study
Device Name eCoin Peripheral Neurostimulator
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Other Data Source
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of premarket cohort to obtain longer term safety and effectiveness data on the eCoin out to 5 years post-implantation
Study Population Subjects diagnosed with Urgency Urinary Incontinence (UUI).
Sample Size Available sample size for longer term follow-up of the original cohort.
The original IDE study was designed to enroll and implant between 120 and 135 patients; it enrolled 137 patients with 4 patients exiting prior to implantation (due to ineligibility). Thus, 133 patients were implanted.
Key Study Endpoints To collect and report clinical outcomes for safety and effectiveness, including 3-day bladder diaries, all device- or procedure-related adverse events, including but not limited to, infections, vasculitis, cellulitis, neuro-sensory and -motor events, device migrations, erosions, unplanned explantations, and re-implantation, to FDA through 5 years post-implantation on patients enrolled in G170301.

Follow-up Visits and Length of Follow-up 5 years, post-implantation
Interim or Final Data Summary
Interim Results N/A
Actual Number of Patients Enrolled 0
Actual Number of Sites Enrolled 13
Patient Follow-up Rate N/A
Study Strengths & Weaknesses Continued follow-up of pivotal study patient cohort will provide more information on the durability of the device, and the safety and effectiveness of the treatment. In addition, the battery which powers the stimulator has a variable life span which could be less than 5 years total time. The continued follow up information will inform us on the re-implantation safety and whether patients are willing to undergo another implantation, i.e., do they feel that the benefit of using the device improves their quality of life sufficiently to undergo additional surgical procedures of device removal and re-implantation.
Recruiting patients for an additional follow-up of 2 years may not be successful. Lost-to-follow-up may be significant.


Continued Follow-Up of G170301 Clinical Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/30/2022 08/31/2022 Overdue/Received
1 year report 03/01/2023    
18 month report 08/30/2023    
2 year report 02/29/2024    
3 year report 02/28/2025    


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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