Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT00638235
Eligibility Criteria:
Inclusion Criteria:
-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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT00638235
Study Brief:
Protocol Section:
NCT00638235