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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-04-19
2021-12-31
Brief Summary
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Detailed Description
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Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period.
During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark's (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
All patients fitted with the device.
Eclipse Insert
Rectal Control System.
Interventions
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Eclipse Insert
Rectal Control System.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Fecal Incontinence
3. Clinician recommendation of the Eclipse System
4. Subject provides informed consent and HIPAA authorization
19 Years
FEMALE
No
Sponsors
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Pelvalon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Pettit, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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The American Association of Female Pelvic Medicine
Agoura Hills, California, United States
The Ob-Gyn and Incontinence Center
Arcadia, California, United States
Long Beach Urogynecology
Long Beach, California, United States
Florida Urogynecology, LLC
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Princeton Urogynecology
Princeton, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Shirley Louis
Role: primary
Kumar Kothandaraman
Role: primary
Dara France
Role: primary
Darlene Jones
Role: primary
Alison Shaltis
Role: primary
Provided Documents
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Document Type: Study Protocol
Related Links
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Pelvalon, Eclipse manufacturer and Study Sponsor, website
Other Identifiers
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CA007
Identifier Type: -
Identifier Source: org_study_id
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