Evaluation of the Performance of the CleanC System-Israel

Study Overview
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Brief Summary
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The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

Detailed Description
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The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS). Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.

Official Title
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Evaluation of the Performance of the CleanC System

Conditions
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Colorectal Cancer (CRC) Screening

Intervention / Treatment
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* Device: CleanC system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects in the age range of 18-75 years Subjects with BMI within the range of 18.5-35 Subject is willing to sign informed consent form Exclusion Criteria: Active or severe inflammatory bowel disease (IBD) Subjects with severe diverticulitis \ diverticular disease (known or detected) Known or detected colonic stenosis Known or detected bowel obstruction History of prior colon surgery ASA≥IV (sever systemic disease) Sever Renal insufficiency (Creatinine≥1.5mg%) Sever Liver insufficiency (ALT/AST≥2UNL) Contraindication for colonoscopy anesthesia \ sedation \ prep agent pregnancy Subjects with altered mental status/inability to provide informed consent Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: CleanC<br>Standard colonoscopy procedure using the CleanC system | Device: CleanC system<br>* Cleansing liquid and fecal matter during a standard colonoscopy procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) | Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy. | During the colonoscopy procedure withdrawal phase (10 min in average) | 
| Safety as Measured by Number of Serious Adverse Events and Major Complications. |  | Max of 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Whom the Cecum Was Reached | A procedure was considered complete when the cecum was reached and visualized. | During the colonoscopy procedure |