Pelvic Organ ProlapseNCT02021279
ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
A study testing MatriStem Pelvic Floor Matrix and native tissue repair in people with Pelvic Organ Prolapse, run by Integra LifeSciences Corporation at 13 sites in United States.
Trial summary
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- MatriStem Pelvic Floor Matrix and native tissue repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 13 sitesUnited States
- Study dates
- 11 Jun 2014to 28 Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's leading edge of POP is at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0 or Bp ≥ 0 or C ≥ 0 (for prolapse of the apical compartment alone) or C ≥ -½ total vaginal length (for a multi-compartment prolapse that includes the apical compartment).
- Subject is seeking surgical intervention for symptomatic POP, which is defined as experiencing symptoms of vaginal bulging or pelvic heaviness. Vaginal bulge or pelvic heaviness will be considered present if a subject responds "yes" (≥1) to PFDI-20, question 3.
- Subject or subject's legally authorized representative is willing to provide written informed consent.
- Subject is willing and able to comply with the follow-up regimen.
Who cannot join
- Subject has a known hypersensitivity to porcine-based materials (relevant to subjects in MatriStem Pelvic Floor Matrix Group only).
- Subject is pregnant or plans to become pregnant during the study.
- Subject has an active or chronic systemic infection including any gynecologic infection, urinary tract infection (UTI), or tissue necrosis.
- Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit).
- Subject has chronic systemic pain syndrome (e.g. fibromyalgia, painful bladder syndrome).
- Subject has a systemic connective tissue disease (e.g., scleroderma, systemic lupus erythematous (SLE), Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica).
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- Subject has uncontrolled diabetes mellitus (DM).
- Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
- Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
- Subject has taken systemic steroids (within the last month), immunosuppressive or immunomodulatory treatment (within the last 3 months).
- Subject is seeking obliterative vaginal surgery as treatment for POP (colpoclesis).
- Subject is not able to conform to the modified dorsal lithotomy position.
- Subject is currently participating in or plans to participate in another device or drug study during this study.
- Subject is to planning to undergo concurrent surgical treatment of prolapse using mesh other than the MatriStem Pelvic Floor Matrix.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Premier Urology Group
Edison, New Jersey, 08837
Center for Pelvic Health
Franklin, Tennessee, 37067
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, 49503
Atlantic Health System
Morristown, New Jersey, 07960
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Princeton Urogynecology
Princeton, New Jersey, 08540
Stanford School of Medicine
Stanford, California, 94305
Cleveland Clinic FLorida
Weston, Florida, 33331
Garden State Urology
Whippany, New Jersey, 07981
About this study
Official title: Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- MatriStem Pelvic Floor Matrix, native tissue repair
- Keywords
- pelvic organ prolapse, MatriStem, pelvic floor matrix, ACell, native tissue repair
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatriStem Pelvic Floor MatrixDevice
native tissue repairProcedure or surgery
Also called suture repair
| Study group | Role | What they receive |
|---|---|---|
| MatriStem Pelvic Floor Matrix | Experimental | surgical mesh device Receives: Device: MatriStem Pelvic Floor Matrix |
| Native Tissue Repair | Active comparator | suture repair Receives: Procedure: native tissue repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and effectiveness of surgical success/failure.
The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse.
Measured: 3 years
Secondary outcomes (1)
The surgical success/failure based on an alternate definition of success.
A composite outcome of surgical success based on an alternate definition of anatomic success, patient reported outcome, and no retreatment for pelvic organ prolapse.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start11 Jun 2014
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021279
- Sponsor's protocol ID
- ACL2012-001
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2013
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT02021279
- Acronym / sponsor ID
- ACL2012-001
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, MatriStem, pelvic floor matrix, ACell, native tissue repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 27 Dec 2013 (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 primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MatriStem Pelvic Floor Matrix | Experimental | Device: MatriStem Pelvic Floor Matrixsurgical mesh device |
| Native Tissue Repair | Active comparator | Procedure: native tissue repairsuture repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject's leading edge of POP is at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0 or Bp ≥ 0 or C ≥ 0 (for prolapse of the apical compartment alone) or C ≥ -½ total vaginal length (for a multi-compartment prolapse that includes the apical compartment).
- Subject is seeking surgical intervention for symptomatic POP, which is defined as experiencing symptoms of vaginal bulging or pelvic heaviness. Vaginal bulge or pelvic heaviness will be considered present if a subject responds "yes" (≥1) to PFDI-20, question 3.
- Subject or subject's legally authorized representative is willing to provide written informed consent.
- Subject is willing and able to comply with the follow-up regimen.
Key exclusion criteria (14 listed)
- Subject has a known hypersensitivity to porcine-based materials (relevant to subjects in MatriStem Pelvic Floor Matrix Group only).
- Subject is pregnant or plans to become pregnant during the study.
- Subject has an active or chronic systemic infection including any gynecologic infection, urinary tract infection (UTI), or tissue necrosis.
- Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit).
- Subject has chronic systemic pain syndrome (e.g. fibromyalgia, painful bladder syndrome).
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 |
|---|---|---|
| MatriStem Pelvic Floor Matrix | Device | MatriStem Pelvic Floor Matrix |
| native tissue repairAlso: suture repair | Procedure or surgery | Native Tissue Repair |
Primary outcome
The safety and effectiveness of surgical success/failure.
Time frame: 3 years
The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse.
1 secondary outcome
The surgical success/failure based on an alternate definition of success.
Time frame: 3 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 8 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MatriStem Pelvic Floor Matrix and native tissue repair in people with Pelvic Organ Prolapse, run by Integra LifeSciences Corporation at 13 sites in United States.
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 4 inclusion and 14 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The safety and effectiveness of surgical success/failure. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2022.