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

2014-07-23 21:13:32 | BioPortfolio

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).

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

Conditions

Pelvic Organ Prolapse

Location

North Shore Private Hospital
Sydney
New South Wales
Australia

Status

Completed

Source

Ethicon, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:32-0400

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Medical and Biotech [MESH] Definitions

Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.

Injury, weakening, or PROLAPSE of the pelvic muscles, surrounding connective tissues or ligaments (PELVIC FLOOR).

Soft tissue formed mainly by the pelvic diaphragm, which is composed of the two levator ani and two coccygeus muscles. The pelvic diaphragm lies just below the pelvic aperture (outlet) and separates the pelvic cavity from the PERINEUM. It extends between the PUBIC BONE anteriorly and the COCCYX posteriorly.

The prolapse or downward displacement of the VISCERA.

The part of the pelvis, inferior to the pelvic brim, that comprises both the pelvic cavity and the part of the PERINEUM lying inferior to the PELVIC DIAPHRAGM.

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