Status:
TERMINATED
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
Lead Sponsor:
Emanuel Trabuco
Collaborating Sponsors:
American Medical Systems
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21-80 years
Phase:
PHASE4
Brief Summary
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
Detailed Description
This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior C...
Eligibility Criteria
Inclusion
- Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
- Require both apical and anterior compartment repairs
- Willing to return for follow-up visit
- Understand and have signed informed consent to undergo randomization
- Need both an apical and anterior repair
- All trial participants who have a uterus will require a hysterectomy
Exclusion
- Known or suspected vulvodynia
- Known or suspected interstitial cystitis
- History of chronic pelvic pain
- Current pregnancy
- Desire to maintain fertility
- History of reconstructive pelvic surgery with synthetic mesh
- History of radical pelvic surgery
- History of pelvic radiation therapy
- Currently undergoing treatment for a malignancy
- Medically poor candidates for surgery
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01497171
Start Date
November 1 2011
End Date
May 1 2013
Last Update
August 21 2014
Active Locations (6)
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1
Kaiser-Permanente - North Valley
Roseville, California, United States, 95661
2
Kaiser-Permanente - Santa Clara
Santa Clara, California, United States, 95051
3
Stanford University School of Medicine
Stanford, California, United States, 94305
4
Washington Hospital Center - MedStar Health
Washington D.C., District of Columbia, United States, 20010