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

Completed

• Conditions: Gastrointestinal signs; 10018012; gastrointestinal symptoms

• Registration Number: NL-OMON42655
• Lead Sponsor: Motus GI Medical Technologies LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Subjects being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria

1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA>=IV
6. Renal insufficiency (Creatinine >= 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST >= 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs or dual antiplatelet therapy
9. Subjects with known coagulation disorder (INR >1.5).
10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
11.Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
12.Subjects with known Mega Colon
13 Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the performance of MCS in cleansing a poorly prepared colon.<br /><br>The rate of adequate cleansing level per subject will be evaluated by the BBPS<br /><br>(The Boston Bowen preparation Scale) scoring index pre- and post the cleansing<br /><br>operation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety related to the MCS. To this purpose, the type,<br /><br>incidence, severity, and duration of adverse events will be assessed. </p><br>