Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829175
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2021-03-17
Brief Title:
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
A Long Term Prospective Observational Post Market Clinical Follow-Up PMCF Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
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 post market clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair with laparotomic or laparoscopic approach including robotic assisted using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP
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