A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
NCT ID: NCT02428595
Last Updated: 2019-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2015-05-15
2018-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Eclipse™ System
Eclipse™ System
The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.
Interventions
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Eclipse™ System
The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject willing and able to give written informed consent to participate in the study
* Subject can read, write and communicate fluently in English
* Subject willing and able to comply with visit schedule
* Subject is able to physically manage the insertion and removal of the Insert
Exclusion Criteria
* Currently pregnant or planning pregnancy during the study period
* Acute infections or genito-urinary injuries that would impact comfortable device use
* Current treatment for Fecal Incontinence other than medical management
* Removal or diversion of any portion of the bowel
* Recent urogenital or colorectal surgeries
* Chronic abdominal pain in absence of diarrhea
* Chronic (\>6 mos) rectal, anal or pelvic pain
* Chronic watery diarrhea, unmanageable by drugs or diet
* Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
* Rectal prolapse (mucosal or full thickness)
* Grade III or IV hemorrhoids
* Pelvic organ prolapse beyond the plane of the hymen
* Concurrent use of intra-vaginal pessary or other device
* Anal or pelvic malignancy within last 5 years
* History of pelvic irradiation for cancer
* Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk
19 Years
FEMALE
No
Sponsors
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Pelvalon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Holly Richter, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama
Birmingham, Alabama, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of North Carolina
Raleigh, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown University (WIHRI)
Providence, Rhode Island, United States
Houston Methodist
Houston, Texas, United States
Providence Sacred Heart
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-547. doi: 10.1097/AOG.0000000000000639.
Richter HE, Dunivan G, Brown HW, Andy U, Dyer KY, Rardin C, Muir T, McNevin S, Paquette I, Gutman RE, Quiroz L, Wu J. A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):113-119. doi: 10.1097/SPV.0000000000000681.
Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study)
Other Identifiers
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CA005
Identifier Type: -
Identifier Source: org_study_id
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