Evaluation of the Performance of the Motus Cleansing System (MCS)

Study Overview
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Brief Summary
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The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.

Detailed Description
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Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands). Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure. Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).

Official Title
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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 (MCS)


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 BodyMass 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) or dual antiplatelet therapy Subjects with known coagulation disorder (INR >1.5). Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl Subjects with active, ongoing lower GI bleeding with hemodynamic instability. Subjects with known Mega Colon 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: Colonoscopy with MCS<br>Standard colonoscopy procedure with Motus Cleansing System | Device: 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of MCS in Cleansing a Poorly Prepared Colon. | The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation. | Up to 2 hours |