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ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study

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ClinicalTrials.gov Identifier: NCT02021279
Recruitment Status : Recruiting
First Posted : December 27, 2013
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
ACell Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: MatriStem Pelvic Floor Matrix Procedure: native tissue repair Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
Study Start Date : June 2014
Estimated Primary Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MatriStem Pelvic Floor Matrix
surgical mesh device
Device: MatriStem Pelvic Floor Matrix
Active Comparator: Native Tissue Repair
suture repair
Procedure: native tissue repair
Other Name: suture repair




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The surgical success/failure based on an alternate definition of success. [ Time Frame: 3 years ]
    A composite outcome of surgical success based on an alternate definition of anatomic success, patient reported outcome, and no retreatment for pelvic organ prolapse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021279


Contacts
Contact: Melinda Wooten 443-283-2786 melindawooten@acell.com
Contact: Elizabeth Smith 443-283-2768 elizabethsmith@acell.com

Locations
United States, California
Stanford School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Kathryn Batham    650-724-7826    kbatham@stanford.edu   
Principal Investigator: Eric Sokol, MD         
United States, Florida
Cleveland Clinic FLorida Recruiting
Weston, Florida, United States, 33331
Contact: Maria Mejia    954-659-5888    mejiagm@ccf.org   
Principal Investigator: Guillermo Davila, MD         
United States, Michigan
Female Pelvic Medicine & Urogynecology Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Beth Rogers    616-588-1135    BRogers@grwh.org   
Principal Investigator: Douglas M Van Drie, MD         
United States, New Jersey
Premier Urology Group Recruiting
Edison, New Jersey, United States, 08837
Contact: Haleema A Hameed    732-494-9400 ext 1220    hhameed@premierurologygroup.com   
Principal Investigator: Neil Sherman, MD         
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Jennifer Pagnillo, RN, BSN    973-971-7267    Jennifer.Pagnillo@atlantichealth.org   
Principal Investigator: Charbel Salamon, MD         
Princeton Urogynecology Recruiting
Princeton, New Jersey, United States, 08540
Contact: Alison Cooke, LPN    609-924-2230    acooke@princetonurogyn.com   
Principal Investigator: Heather van Raalte, MD         
Garden State Urology Recruiting
Whippany, New Jersey, United States, 07981
Contact: Darlene Wendling    973-971-5373    Darlene.Wendling@atlantichealth.org   
Principal Investigator: Michael Ingber, MD         
United States, New York
Premier Medical Group of the Hudson Valley Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Lauren Passante    845-437-5002    lpassante@premiermedicalhv.com   
Principal Investigator: Daniel Katz, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Sharon Lamping    513-585-2166    sharon.lamping@thechristhospital.com   
Principal Investigator: Mickey Karram, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ly Pung, RN    216-445-2494    PUNGL@ccf.org   
Principal Investigator: Marie Paraiso, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kelly Burton, RN    405-271-1615    Kelly-Burton@ouhsc.edu   
Principal Investigator: Mikio Nihira, MD         
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Marcie Taff    610-435-9575 ext 103    mtaff@fpminstitute.com   
Principal Investigator: Vincent Lucente, MD, MBA         
United States, Tennessee
Center for Pelvic Health Recruiting
Franklin, Tennessee, United States, 37067
Contact: Laura Matthews    615-499-4740    lmatthews@associatesingastro.com   
Principal Investigator: Barry Jarnagin, MD         
Sponsors and Collaborators
ACell Inc.

Responsible Party: ACell Inc.
ClinicalTrials.gov Identifier: NCT02021279     History of Changes
Other Study ID Numbers: ACL2012-001
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016

Keywords provided by ACell Inc.:
pelvic organ prolapse
MatriStem
pelvic floor matrix
ACell
native tissue repair

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical