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

• ClinicalTrials.gov Identifier: NCT02021279
• Recruitment Status: Active, not recruiting
• First Posted: December 27, 2013
• Last Update Posted: March 19, 2020
• Sponsor: ACell Inc.
• Information provided by (Responsible Party): ACell Inc.

Study Description

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	Not Applicable

Study Design

• 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: August 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, California

Stanford School of Medicine

Stanford, California, United States, 94305

United States, Florida

Cleveland Clinic FLorida

Weston, Florida, United States, 33331

United States, Michigan

Female Pelvic Medicine & Urogynecology

Grand Rapids, Michigan, United States, 49503

United States, New Jersey

Premier Urology Group

Edison, New Jersey, United States, 08837

Atlantic Health System

Morristown, New Jersey, United States, 07960

Princeton Urogynecology

Princeton, New Jersey, United States, 08540

Garden State Urology

Whippany, New Jersey, United States, 07981

United States, New York

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States, 12601

United States, Ohio

The Christ Hospital

Cincinnati, Ohio, United States, 45219

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, United States, 18103

United States, Tennessee

Center for Pelvic Health

Franklin, Tennessee, United States, 37067

Sponsors and Collaborators

ACell Inc.

More Information

• Responsible Party: ACell Inc.
• ClinicalTrials.gov Identifier: NCT02021279
• Other Study ID Numbers: ACL2012-001
• First Posted: December 27, 2013
• Last Update Posted: March 19, 2020
• Last Verified: March 2020

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