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The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

NCT01497171 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-08-21

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Elevate Mesh

Transvaginal mesh repair of anterior vaginal prolapse

PROCEDURE

Anterior Colporrhaphy

Traditional suture repair of anterior vaginal prolapse

Sponsors & Collaborators

  • American Medical Systems

    collaborator INDUSTRY

  • Emanuel Trabuco

    lead OTHER

Principal Investigators

  • Emanuel Trabuco, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497171 on ClinicalTrials.gov