Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT04829994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
Sponsor:
Ethicon, Inc.
Organization:
Study Overview
Official Title:
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: