N/A
Completed N=10
Evaluation of the Performance of the CleanC System-Israel
Colorectal Cancer (CRC) Screening
Source: ClinicalTrials.gov NCT02387268 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) — 88.9 percentage of 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 Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) |
88.9 | — |
| PRIMARY Safety as Measured by Number of Serious Adverse Events and Major Complications. |
— | — |
| SECONDARY Percentage of Participants in Whom the Cecum Was Reached |
88.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects in the age range of 18-75 years
- Subjects with BMI within the range of 18.5-35
- Subject is willing to sign informed consent form
Exclusion Criteria
- Active or severe inflammatory bowel disease (IBD)
- Subjects with severe diverticulitis \ diverticular disease (known or detected)
- Known or detected colonic stenosis
- Known or detected bowel obstruction
- History of prior colon surgery
- ASA≥IV (sever systemic disease)
- Sever Renal insufficiency (Creatinine≥1.5mg%)
- Sever Liver insufficiency (ALT/AST≥2UNL)
- Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent
- pregnancy
- Subjects with altered mental status/inability to provide informed consent
- Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Data sourced from ClinicalTrials.gov (NCT02387268). 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.