Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

ACell Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: MatriStem Pelvic Floor Matrix
  • Procedure: native tissue repair

Phase:

Phase 4

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tine Bjornlund
650-724-7826
Recruiting