Status:
COMPLETED
Pelvic Floor Repair Systems for Prolapse Repair
Lead Sponsor:
ASTORA Women's Health
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21+ years
Brief Summary
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Fl...
Eligibility Criteria
Inclusion
- Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
Exclusion
- The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
- Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
- Subject has active or latent systemic infection or signs of tissue necrosis.
- Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
- Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
- Subject has had radiation therapy to the pelvic area.
- Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- Subject has a known hypersensitivity to the graft material(s).
- Subject has uncontrolled diabetes.
- Subject is on any medication which could result in compromised immune response, such as immune modulators.
- Subject was involved in any other research trial \< 30 days of enrollment into this study.
- Subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study.
- Subject is unwilling or unable to give valid informed consent.
- Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
- Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
725 Patients enrolled
Trial Details
Trial ID
NCT00638235
Start Date
May 1 2006
End Date
September 1 2012
Last Update
October 28 2016
Active Locations (28)
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1
Kaiser Permanente - Dept. of Obstetrics & Gynecology
Downey, California, United States, 90242
2
Institute for Women's Health & Body
Wellington, Florida, United States, 33414
3
Atlanta Medical Research Institute
Alpharetta, Georgia, United States, 30005
4
Rosemark Womencare Specialists
Idaho Falls, Idaho, United States, 83404