Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products



Status:Archived
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011

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The Prolapse Registry: A Prospective Observational Study of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse


Observational (meaning that we are simply collecting whatever information the surgeon
typically collects when they see their patients; there is no change to the care the patient
receives as a result of being part of the registry) data collection on the surgical outcomes
of AMS prolapse products; we predict that patients will be significantly improved as a
result of the surgery.


The Prolapse Registry is an observational study of patients who are implanted with AMS
devices for the surgical repair of female pelvic prolapse. The registry will follow
patients post-operatively for up to 2 years and will collect demographic, clinical,
surgical, safety, and patient outcomes data.

The registry is a web-based system in which surgeons enter patient information with regard
to their prolapse surgery. All information entered is de-identified (no names, no date of
birth, no date of surgery, etc).


We found this trial at
1
site
Whitinsville, Massachusetts 01588
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Whitinsville, MA
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