The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.
This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure. Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation. Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system. In case of inadequate bowel preparation, as per the nurse report and / or BBPS \< 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu. Follow-up will be conducted at 48 hours (± 48 hours) post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
95
The Pure-Vu System is FDA cleared device and CE marking received in February 2018, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
Washington University School of Medicine
St Louis, Missouri, United States
The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System
The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated using the Boston Bowel Preparation Scale (BBPS). Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side) summed for the maximum score of 9 (0= dirtiest and 9= pristine). An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.
Time frame: up to 2 hours
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