Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828979
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2023-04-12
Brief Title:
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women
Sponsor:
UroMems SAS
Organization:
UroMems SAS
Study Overview
Official Title:
Feasibility sTudy to Assess the URoMems Artificial uriNary Sphincter In the Treatment of Stress Incontinence in wOmeN
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter in women
Detailed Description:
This study is a prospective open-label non-randomized multi-center single-arm study with subjects acting as their own control designed to test the feasibility of a new artificial urinary sphincter the UroMems eAUS investigational name of device called UroActive in women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None