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

Conditions:Women's Studies
Therapuetic Areas:Reproductive
Age Range:18 - Any
Start Date:June 2014
Contact:Melinda Wooten

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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.

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

- 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

- 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.
We found this trial at
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Principal Investigator: Daniel Katz, MD
Phone: 845-437-5002
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
Poughkeepsie, NY
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
Principal Investigator: Guillermo Davila, MD
Phone: 954-659-5888
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
Weston, FL
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Allentown, Pennsylvania 18105
Principal Investigator: Vincent Lucente, MD, MBA
Phone: 610-435-9575
Allentown, PA
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Mickey Karram, MD
Phone: 513-585-2166
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
Cincinnati, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Marie Paraiso, MD
Phone: 216-445-2494
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Cleveland, OH
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Edison, New Jersey 08837
Principal Investigator: Neil Sherman, MD
Phone: 732-494-9400
Edison, NJ
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Franklin, Tennessee 37067
Principal Investigator: Barry Jarnagin, MD
Phone: 615-499-4740
Franklin, TN
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Grand Rapids, Michigan 49503
Principal Investigator: Douglas M Van Drie, MD
Phone: 616-588-1135
Grand Rapids, MI
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Morristown, New Jersey 07960
Principal Investigator: Charbel Salamon, MD
Phone: 973-971-7267
Morristown, NJ
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Mikio Nihira, MD
Phone: 405-271-1615
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
Oklahoma City, OK
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Princeton, New Jersey 08540
Principal Investigator: Heather van Raalte, MD
Phone: 609-924-2230
Princeton, NJ
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Stanford, California 94305
Principal Investigator: Eric Sokol, MD
Phone: 650-724-7826
Stanford, CA
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Whippany, New Jersey 07981
Principal Investigator: Michael Ingber, MD
Phone: 973-971-5373
Whippany, NJ
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