The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
Stopped early · Phase 4
Conditions studied: Pelvic Organ Prolapse
In brief
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.
Key facts
- Study ID
- NCT01497171
- Run by
- Emanuel Trabuco
- People needed
- 5
- Starts
- 2011-11-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2014-08-21
Who can join
Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kaiser-Permanente - North Valley — Roseville, California, United States
- Kaiser-Permanente - Santa Clara — Santa Clara, California, United States
- Stanford University School of Medicine — Stanford, California, United States
- Washington Hospital Center - MedStar Health — Washington D.C., District of Columbia, United States
- The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
- St. Hedwig's Krankenhaus — Berlin, Germany
Full record on ClinicalTrials.gov
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