Pelvic Organ ProlapseNCT00860912
Veritas Collagen Matrix Cystocele Repair Study - Postmarketing
A study testing Collagen Matrix in people with Pelvic Organ Prolapse, run by The Cleveland Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Collagen Matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the detailed description
Surgery for cystocele repair to be performed. Native tissue repair to be randomized versus reinforcement with Collagen matrix
.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Collagen Matrix
- Keywords
- Veritas, Cystocele, Prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen MatrixProcedure or surgery
Also called Veritas collagen matrix
surgical/reinforcing material
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Collagen matrix | Experimental | Cystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix Receives: Procedure: Collagen Matrix |
| Native tissue repair | Other | Intervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues. Receives: Procedure: Collagen Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
subjective satisfaction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startDec 2001
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- collagen graft reinforcement
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillermo W Davila, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860912
- Sponsor's protocol ID
- IRB# 85852010
- Status last verified
- Apr 2017
- First submitted
- 12 Mar 2009
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19546759
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
- ClinicalTrials.gov ID
- NCT00860912
- Acronym / sponsor ID
- IRB# 85852010
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Veritas, Cystocele, Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- collagen graft reinforcement
| Arm | Type | Receives |
|---|---|---|
| Intervention: Collagen matrix | Experimental | Procedure: Collagen MatrixCystocele repair: Veritas reinforcing material implanted for reinforcement of cystocele repair with collagen matrix |
| Native tissue repair | Other | Procedure: Collagen MatrixIntervention: Cystocele repair performed: No reinforcing material used and routine performance of a cystocele repair using native tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen MatrixAlso: Veritas collagen matrixsurgical/reinforcing material | Procedure or surgery | Intervention: Collagen matrix, Native tissue repair |
Primary outcome
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
1 secondary outcome
To evaluate patient satisfaction as measured by a comparison of Quality of Life questions at baseline and post surgery
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Derived from this study: PubMed 19546759Guerette 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo W Davila, MD principal investigator
Cleveland Clinic Florida
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Matrix in people with Pelvic Organ Prolapse, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.