Trials / Completed
CompletedNCT00521066
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Detailed description
The GYNECARE PROSIMA\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GYNECARE PROSIMA* Pelvic Floor Repair System | procedure for pelvic organ prolapse |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2008-10-01
- Completion
- 2010-06-01
- First posted
- 2007-08-27
- Last updated
- 2014-05-06
Locations
11 sites across 4 countries: United States, Australia, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT00521066. Inclusion in this directory is not an endorsement.