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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Disease, Colorectal Cancer

Intervention / Treatment
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* Device: Pure-Vu System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy Patients' age > 22 years Patient has signed the informed consent Exclusion Criteria: Patients with known Inflammatory Bowel Disease and / or active Colitis Patients with active diverticulitis Patients with known or detected (during colonoscopy) bowel obstruction Patients with BMI ≤ 18 Patients with ascites Child Pugh C Patients who are 30 days post-transplant Patients treated with Peritoneal dialysis Patients under active IV inotropic medications Patients with LVAD Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician) Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000) Subjects with hemodynamic instability. Pregnancy (as stated by patient) or breast feeding Subjects with altered mental status/inability to provide informed consent Patients who have participated in another interventional clinical study in the last 2 months

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy with Pure-Vu System<br>Standard colonoscopy procedure with Pure-Vu System | Device: Pure-Vu System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel prepartion