Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System

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 main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy

Official Title
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Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System

Conditions
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CRC

Intervention / Treatment
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* Device: Motus Cleansing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects being considered for diagnostic, screening or surveillance colonoscopy Subjects in the age range of 18-75 years inclusive Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive Subject has signed the informed consent Exclusion Criteria: Subjects with known Inflammatory Bowel Disease Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease Subjects with known or detected (during colonoscopy) bowel obstruction History of prior surgery to colon and/or rectum ASA≥IV Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history) Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history) Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy 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: 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: Motus Cleansing System (MCS)<br>The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir. | Device: Motus Cleansing System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS | The rating of the cleansing quality was evaluated by 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): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS>1 in all colon segments | Within 24 hours- During the colonoscopy procedure |