Trials / Unknown
UnknownNCT02921451
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Michigan Institution of Women's Health PC · Academic / Other
- Sex
- Female
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Restorelle Smartmesh | Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2020-08-01
- Completion
- 2020-08-01
- First posted
- 2016-10-03
- Last updated
- 2019-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02921451. Inclusion in this directory is not an endorsement.