Motus GI Medical Technologies Ltd
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. 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 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).
- Device: Motus Cleansing System (MCS)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.
|Ages eligible for Study||18 Years to 75 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||Accepts Healthy Volunteers|
- 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
- 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
- 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
- UMC Of JOHANNES GUTENBERG-UNIVERSITY MAINZMainz, Germany
- University Medical Centre (UMC) Radboud Department of Gastroenterology and HepatologyNijmegen, Netherlands
- Erasmus medical centerRotterdam, Netherlands
21 December, 2016
11 June, 2017