Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02921451
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2016-09-23
Brief Title:
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Sponsor:
Michigan Institution of Womens Health PC
Organization:
Michigan Institution of Womens Health PC
Study Overview
Official Title:
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 determine the long term performance of Restorelle system for the treatment of uterine prolapse
Detailed Description:
This study is being done to evaluate the performance of the Restorelle system which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management Most patients undergo a hysterectomy ie removal of the uterus when they have a prolapse However this has often been found to be an unnecessary operation The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse
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