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
79 participants
OBSERVATIONAL
2014-08-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exair for Total Repair
Total repair with Exair Prolapse Repair System alone or in combination with native tissue repair
Exair Prolapse Repair System
Total Native Tissue Repair
Total repair with native tissue only
Total Native Tissue Repair
Interventions
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Exair Prolapse Repair System
Total Native Tissue Repair
Eligibility Criteria
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Inclusion Criteria
* Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and Bp ≥0 and C≥ -1/2 tvl
* 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 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 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), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, 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(s)
18 Years
FEMALE
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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James Lukban, DO, FACOG
Role: PRINCIPAL_INVESTIGATOR
The Pelvic Solutions Center
Locations
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Progressive GYN Center
Savannah, Georgia, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Advanced Urogynecology of Michigan
Dearborn, Michigan, United States
Minnesota Women's Care
Maplewood, Minnesota, United States
Atlantic Urogynecology Associates
Morristown, New Jersey, United States
Princeton Urogynecology
Princeton, New Jersey, United States
Albany Medical Center
Albany, New York, United States
United Health Services
Johnson City, New York, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Novant Health Clinical Research
Winston-Salem, North Carolina, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States
Vermont Urogynecology Associates, P.C.
Williston, Vermont, United States
Carillion Clinic OB/GYN
Christiansburg, Virginia, United States
CHUS-CRC
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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SU019
Identifier Type: -
Identifier Source: org_study_id