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

Evaluation of the Performance of the Motus Cleansing System (MCS) - CL00016

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42655

Enrollment

Registered

2016-08-01

Start date

2016-12-20

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal signs gastrointestinal symptoms

Interventions

Use of Motus Cleansing System (MCS)to enable colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is co

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To evaluate the performance of MCS in cleansing a poorly prepared colon. The rate of adequate cleansing level per subject will be evaluated by the BBPS (The Boston Bowen preparation Scale) scoring index pre- and post the cleansing operation.	—

Secondary

Measure	Time frame
To evaluate the safety related to the MCS. To this purpose, the type, incidence, severity, and duration of adverse events will be assessed.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)