Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT00521066
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2007-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
Sponsor:
Ethicon, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse
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 purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.
(\*TRADEMARK)
(\*TRADEMARK)
Detailed Description:
The GYNECARE PROSIMA\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.
Study Oversight
Has Oversight DMC:
False
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?: