Clinical trial NCT03026075: Evaluation of the Performance of the Motus Cleansing System (MCS)
Official title: Evaluation of the Performance of the Motus Cleansing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CRC
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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: 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).

Eligibility 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:

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

Primary outcomes:
measure: Performance of MCS in Cleansing a Poorly Prepared Colon.
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: UMC Of JOHANNES GUTENBERG-UNIVERSITY MAINZ
city: Nijmegen
country: Netherlands
facility: University Medical Centre (UMC) Radboud Department of Gastroenterology and Hepatology
city: Rotterdam
country: Netherlands
facility: Erasmus medical center
Study officials:
affiliation: Motus GI Technologies Ltd.
name: Ravit Peled
role: STUDY_DIRECTOR
References:
citation: van Keulen KE, Neumann H, Schattenberg JM, van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.