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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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Post-Approval Study of eCoin - RECIPE


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General
Study Status Delayed
Application Number /
Requirement Number		 P200036 / PAS002
Date Original Protocol Accepted 03/30/2022
Date Current Protocol Accepted 11/30/2022
Study Name Post-Approval Study of eCoin - RECIPE
Device Name eCoin Peripheral Neurostimulator
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This PAS is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoin tibial nerve stimulation in subjects having UUI. Subjects will be screened.
Study Population The study population will consist of eligible patients (adults above 18 years old) with a diagnosis of UUI. Baseline assessment will include complete medical history, physical examination, and completion of a 3-day voiding diary to quantify voiding behavior, symptoms, and incontinence. Only subjects who meet all the inclusion and exclusion criteria, and have provided informed consent, will be enrolled.
Sample Size The target enrollment for this study is 200 subjects.
Key Study Endpoints All study data will be recorded onto electronic Case Report Forms (eCRFs) in an electronic data capture (EDC) system. All eCRFs will be completed using de-identified data. The EDC system will maintain the integrity of patient privacy using a secure server and patient information is still de-identified, using patient numbers only. The protocol identifies measures the sponsor will use to help ensure data reliability and quality control, including training of study personnel responsible for entering all data into the eCRF system, use of a central database (data entered in the eCRF will be immediately saved and changes tracked to provide for an audit trail), Source Data Verification (SDV) performed per the clinical monitoring plan, and locking data upon verification to prevent further editing.
Follow-up Visits and Length of Follow-up 60 months post activation


Post-Approval Study of eCoin - RECIPE Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/30/2022 08/26/2022 On Time
1 year report 03/01/2023 02/24/2023 On Time
18 month report 08/30/2023 08/29/2023 On Time
2 year report 02/29/2024 02/26/2024 On Time
30 month report 08/30/2024    
3 year report 03/01/2025    


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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