Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453739
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2007-03-28
Brief Title:
TVT Worldwide Registry
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
TVT-World Wide Observational Registry for Long-Term Data
Status:
COMPLETED
Status Verified Date:
2014-05
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 observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT Tension-Free Vaginal Tape systems in women with stress urinary incontinence
Detailed Description:
Sites may include patients with either the GYNECARE TVT SECUR System GYNECARE TVT System or the GYNECARE TVT Obturator System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None