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The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

This study has been terminated.
(Early termination of study due to changes in funding.)
Sponsor:
Collaborator:
American Medical Systems
Information provided by (Responsible Party):
Emanuel Trabuco, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01497171
First received: December 20, 2011
Last updated: August 6, 2014
Last verified: August 2014

December 20, 2011
August 6, 2014
November 2011
May 2013   (final data collection date for primary outcome measure)
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.
Same as current
Complete list of historical versions of study NCT01497171 on ClinicalTrials.gov Archive Site
Not Provided
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The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial

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.

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 Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair.

The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function.

The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Pelvic Organ Prolapse
  • Procedure: Elevate Mesh
    Transvaginal mesh repair of anterior vaginal prolapse
  • Procedure: Anterior Colporrhaphy
    Traditional suture repair of anterior vaginal prolapse
  • Active Comparator: Elevate Mesh
    Elevate transvaginal mesh - surgical repair of prolapse
    Intervention: Procedure: Elevate Mesh
  • Active Comparator: Anterior Colporrhaphy
    Anterior colporrhaphy - surgical repair of prolapse
    Intervention: Procedure: Anterior Colporrhaphy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Female
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01497171
11-000247
No
Emanuel Trabuco, Mayo Clinic
Emanuel Trabuco
American Medical Systems
Principal Investigator: Emanuel Trabuco, MD Mayo Clinic
Mayo Clinic
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP