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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
  Purpose
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.

Condition Intervention
Pelvic Organ Prolapse Procedure: Collagen Matrix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
collagen graft reinforcement
Masking: Participant
Primary Purpose: Treatment
Official Title: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 94
Study Start Date: December 2001
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention: Collagen matrix
Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix
Procedure: Collagen Matrix
surgical/reinforcing material
Other Name: Veritas collagen matrix
Native tissue repair
Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
Procedure: Collagen Matrix
surgical/reinforcing material
Other Name: Veritas collagen matrix

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860912

Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Guillermo W Davila, MD Cleveland Clinic Florida
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00860912     History of Changes
Other Study ID Numbers: IRB# 85852010
Study First Received: March 12, 2009
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Veritas
Cystocele
Prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Cystocele
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 22, 2017