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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
Results First Received: August 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Pelvic Organ Prolapse
Interventions: Procedure: Elevate Mesh
Procedure: Anterior Colporrhaphy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
5 women were enrolled at the German site (St. Hedwig's). No subjects were enrolled at the US sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Elevate Mesh

Elevate transvaginal mesh - surgical repair of prolapse

Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse

Anterior Colporrhaphy

Anterior colporrhaphy - surgical repair of prolapse

Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse


Participant Flow:   Overall Study
    Elevate Mesh     Anterior Colporrhaphy  
STARTED     2     3  
COMPLETED     2     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
5 women were enrolled at the German site (St. Hedwig's). No subjects were enrolled at the US sites.

Reporting Groups
  Description
Elevate Mesh Transvaginal mesh repair of anterior vaginal prolapse
Anterior Colporrhaphy Traditional suture repair of anterior vaginal prolapse
Total Total of all reporting groups

Baseline Measures
    Elevate Mesh     Anterior Colporrhaphy     Total  
Number of Participants  
[units: participants]
  2     3     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     1     2     3  
Gender  
[units: participants]
     
Female     2     3     5  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Germany     2     3     5  



  Outcome Measures

1.  Primary:   Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of study due to changes in funding.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Emanuel C. Trabuco
Organization: Mayo Clinic
phone: 507-284-7519
e-mail: trabuco.emanuel@mayo.edu


No publications provided


Responsible Party: Emanuel Trabuco, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01497171     History of Changes
Other Study ID Numbers: 11-000247
Study First Received: December 20, 2011
Results First Received: August 6, 2014
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board