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Standard colonoscopy procedure with Pure-Vu System

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.

Pure-Vu System

Annie Choi

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.

Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System

no plan to share the individual participated date with other researchers at this point.

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.

Motus GI Medical Technologies Ltd

Inpatient colonoscopy procedure with Pure-Vu System

Pure-Vu System: 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.

Colonoscopy With Pure-Vu System

Inpatient colonoscopies with Pure-Vu System- Single Arm

Pure-Vu System: The Pure-Vu System is FDA cleared device 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.

Age, Customized

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Germany

Region of Enrollment

Director of Clinical Operations

Rate of adequate preparation measured by BBPS before Pure-Vu Use

Rate of adequate preparation measured by BBPS after Pure-Vu Use

Rate of Adequacy of bowel preparation using the Boston Bowel Preparation Score (BBPS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System	NCT03503162	Gastrointestina... Colorectal Canc...	Pure-Vu System	22 Years -	Motus GI Medical Technologies Ltd
Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System	NCT03503162	Gastrointestina... Colorectal Canc...	Pure-Vu System	22 Years -	Motus GI Medical Technologies Ltd

Spots Global Cancer Trial Database for bowel prepartion