Back to resultsVeritas Collagen Matrix Cystocele Repair Study - Postmarketing
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Collagen Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Veritas, Cystocele, Prolapse
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention: Collagen matrix
Native tissue repair
Arm Description
Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix
Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
Outcomes
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
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
subjective satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00860912
Brief Title
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
Official Title
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Veritas, Cystocele, Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
collagen graft reinforcement
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Collagen matrix
Arm Type
Experimental
Arm Description
Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix
Arm Title
Native tissue repair
Arm Type
Other
Arm Description
Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
Intervention Type
Procedure
Intervention Name(s)
Collagen Matrix
Other Intervention Name(s)
Veritas collagen matrix
Intervention Description
surgical/reinforcing material
Primary Outcome Measure Information:
Title
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
Description
prolapse degree on pelvic exam
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
Description
subjective satisfaction
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo W Davila, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19546759
Citation
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.
Results Reference
derived
Learn more about this trial
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
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