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Veritas Collagen Matrix Cystocele Repair Study - Postmarketing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00860912
First received: March 12, 2009
Last updated: April 18, 2017
Last verified: April 2017
March 12, 2009
April 18, 2017
December 2001
May 2007   (Final data collection date for primary outcome measure)
To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery [ Time Frame: 2 years ]
prolapse degree on pelvic exam
To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery
Complete list of historical versions of study NCT00860912 on ClinicalTrials.gov Archive Site
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery [ Time Frame: 2 years ]
subjective satisfaction
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
Not Provided
Not Provided
 
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.

Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
collagen graft reinforcement
Masking: Single (Participant)
Primary Purpose: Treatment
Pelvic Organ Prolapse
Procedure: Collagen Matrix
surgical/reinforcing material
Other Name: Veritas collagen matrix
  • Experimental: Intervention: Collagen matrix
    Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix
    Intervention: Procedure: Collagen Matrix
  • Native tissue repair
    Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
    Intervention: Procedure: Collagen Matrix
Guerette NL, Peterson TV, Aguirre OA, Vandrie DM, Biller DH, Davila GW. Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial. Obstet Gynecol. 2009 Jul;114(1):59-65. doi: 10.1097/AOG.0b013e3181a81b41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
May 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is equal or greater than 18 years old
  • Female
  • Meets follow-up evaluation time frame
  • Understands the nature of the procedure and has provided written informed consent
  • Is scheduled to undergo vaginal pelvic reconstructive surgery
  • Has > 2nd degree midline cystocele

Exclusion Criteria:

  • Presence of severe mucosal ulceration
  • Previous pelvic organ prolapse surgery using an implant that will affect the use of the VCM or affect the outcome of the study
  • Allergy to bovine material
  • Severe mucosal atrophy
  • Shortened vaginal length as determined by Investigator
  • Pregnant or intends to become pregnant during study
  • Has a UTI
  • Has vault prolapse < 2nd degree cystocele
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00860912
IRB# 85852010
No
Not Provided
Plan to Share IPD: No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Guillermo W Davila, MD Cleveland Clinic Florida
The Cleveland Clinic
April 2017

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