Post-Approval Studies (PAS) Database

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

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
Clinical Trial Number(s)	NCT03556891
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	08/29/2024	On Time
3 year report	03/01/2025

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background