N/A
N=47
Evaluation of the Performance of the Motus Cleansing System (MCS)
CRC
Bottom Line
View on ClinicalTrials.gov: NCT03026075 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Performance of MCS in Cleansing a Poorly Prepared Colon. — 46; 9 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motus Cleansing System (MCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Motus GI Medical Technologies Ltd
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance of MCS in Cleansing a Poorly Prepared Colon. |
46; 9 | <0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- ASA≥IV
- 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
Data sourced from ClinicalTrials.gov (NCT03026075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.