Trials / Completed
CompletedNCT00965952
A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse
A Prospective, Observational Surgical Simulation Study to Evaluate the Safety of the VFIX Device Mechanism as Treatment for Vaginal Apical Prolapse
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 49 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).
Detailed description
In this study, the surgeon will not use the actual V-Fix device. Instead, the surgeon will use a routine operating room instrument, which is similar to the size and shape of the V-Fix device to mimic the placement of the VFIX device by using the routine operating room instrument to push the top of your vagina towards the ligament.
Conditions
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2009-08-26
- Last updated
- 2010-02-10
Locations
4 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT00965952. Inclusion in this directory is not an endorsement.