N/A
Completed N=10
Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System
CRC
Source: ClinicalTrials.gov NCT02572076 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS — 9 Participants
Summary
The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS |
9 | — |
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 Body Mass 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) and dual anti-platelet therapy
- 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 (NCT02572076). 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. Informational only — not medical advice.