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

Motus GI

Status: Completed

Conditions: CRC

Treatments: Device: Motus Cleansing System (MCS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03026075

CL00016

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 47 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 (excluding aspirin) 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Colonoscopy with MCS

Experimental group

Description:

Standard colonoscopy procedure with Motus Cleansing System

Treatment:

Device: Motus Cleansing System (MCS)