Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829357
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2021-03-12
Brief Title:
Post Market Clinical Follow-up Study on TVT ABBREVO Continence System
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
A Long Term Prospective Post Market Clinical Follow-up PMCF of the GYNECARE TVT ABBREVO Continence System for the Treatment of Stress Urinary Incontinence
Status:
RECRUITING
Status Verified Date:
2024-10
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 ABBREVO Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence SUI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None