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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-11

Study Completion Date

2021-04-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MatriStem Pelvic Floor Matrix

surgical mesh device

Group Type EXPERIMENTAL

MatriStem Pelvic Floor Matrix

Intervention Type DEVICE

Native Tissue Repair

suture repair

Group Type ACTIVE_COMPARATOR

native tissue repair

Intervention Type PROCEDURE

Interventions

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MatriStem Pelvic Floor Matrix

Intervention Type DEVICE

native tissue repair

Intervention Type PROCEDURE

Other Intervention Names

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suture repair

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No