LIBERATE-A Clinical Evaluation of the Eclipse System; a Vagi Bowel Control nal(VBC) Therapy for Fecal Incontinence in Women
Brief description of study
Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL), meaning you do not always have control over your bowels. Your study doctor has determined that your loss of bowel control might be helped by the LIBERATE study device, which is called the Eclipse System.
Contact: Lorraine Flick/Michelle Kinglee/Akudo Ejeluno
Phone: 215-615-6569
Detailed description of study
The purpose of this study is to evaluate the long term use of the Eclipse System to treat ABL in adult women. Your study participation may last for approximately 15 months, with up to 10 study visits. The first few visits may take from 1 to 1.5 hours each. The later visits may take a half hour to 1 hour each. 150 subjects will be enrolled at approximately 15 sites into the 12 month Treatment Period. The information obtained in this study will be used to help understand the effectiveness and safety of the Eclipse Insert (described below) while wearing the device for up to 12 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
ACCIDENTAL BOWEL LEAKAGE
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Age: Between 19 Years - 92 Years
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Gender: Female
Updated on
22 Jul 2015.
Study ID: TX349
