Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
1 other identifier
interventional
94
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2001
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedApril 20, 2017
April 1, 2017
5.4 years
March 12, 2009
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Secondary Outcomes (1)
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
2 years
Study Arms (2)
Intervention: Collagen matrix
EXPERIMENTALCystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix
Native tissue repair
OTHERIntervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues.
Interventions
surgical/reinforcing material
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19546759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo W Davila, MD
Cleveland Clinic Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
December 1, 2001
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
April 20, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share