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A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
A Prospective, Observational Surgical Simulation Study to Evaluate the Safety of the VFIX Device Mechanism as Treatment for Vaginal Apical Prolapse

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00965952
Study type Observational
Source Ethicon, Inc.
Contact
Status Completed
Phase N/A
Start date July 2009
Completion date December 2009
View Details
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