Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-22 @ 8:15 AM
Study NCT ID:
NCT02921451
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2016-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Sponsor:
Michigan Institution of Women's Health PC
Organization:
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 i.e. 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:
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?: