Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
NCT ID: NCT02123992
Last Updated: 2016-09-07
Study Results
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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TERMINATED
PHASE4
99 participants
INTERVENTIONAL
2014-04-30
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Elevate Apical and Posterior
The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse
Elevate Apical and Posterior
Native Tissue Repair
The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures
Native Tissue Repair for pelvic organ prolapse
Interventions
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Elevate Apical and Posterior
Native Tissue Repair for pelvic organ prolapse
Eligibility Criteria
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Inclusion Criteria
Subject is at least 18 years of age
Subject must have documented diagnosis of posterior or posterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior prolapse that includes the apical compartment)
Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
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 an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
Subject has 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), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
Subject has uncontrolled diabetes mellitus (DM)
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 is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
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 has a known sensitivity to polypropylene
Subject has had previous prolapse repair with mesh in the target compartment
Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
18 Years
FEMALE
No
Sponsors
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ASTORA Women's Health
INDUSTRY
Responsible Party
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Principal Investigators
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Eric R Sokol, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Urological Associates of Southern Arizona
Tucson, Arizona, United States
The Clark Center for Urogynecology
Newport Beach, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Metro Urology
Woodbury, Minnesota, United States
Adult & Pediatric Urology and Urogynecology
Omaha, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Delaware Valley Urology
Mount Laurel, New Jersey, United States
Princeton Medical Center
Princeton, New Jersey, United States
The Center for Specialized Women's Health
Whippany, New Jersey, United States
North Shore Women's Health Clinic
Great Neck, New York, United States
Premier Medical Group
Poughkeepsie, New York, United States
The Institute for Female Pelvic Medicine - St. Luke's Hospital
Allentown, Pennsylvania, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, United States
Swan Urogynecology
Nashville, Tennessee, United States
The Womens Centre
Denton, Texas, United States
University of Texas at Galveston
Galveston, Texas, United States
Lone Star Urogynecology and Continence Center
Round Rock, Texas, United States
Female Pelvic Medicine Institute of Virginia
North Chesterfield, Virginia, United States
Athena Women's Health
Issaquah, Washington, United States
University of Washington Pelvic Health Center
Seattle, Washington, United States
Countries
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Other Identifiers
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PR1206
Identifier Type: -
Identifier Source: org_study_id
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