Colorectal Cancer (CRC) Screening Clinical Trial
Official title:
Evaluation of the Performance of the "CleanC" System
| Verified date | February 2016 |
| Source | Motus GI Medical Technologies Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | November 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Subjects in the age range of 18-75 years 2. Subjects with BMI within the range of 18.5-35 3. Subject is willing to sign informed consent form Exclusion Criteria: 1. Active or severe inflammatory bowel disease (IBD) 2. Subjects with severe diverticulitis \ diverticular disease (known or detected) 3. Known or detected colonic stenosis 4. Known or detected bowel obstruction 5. History of prior colon surgery 6. ASA=IV (sever systemic disease) 7. Sever Renal insufficiency (Creatinine=1.5mg%) 8. Sever Liver insufficiency (ALT/AST=2UNL) 9. Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent 10. pregnancy 11. Subjects with altered mental status/inability to provide informed consent 12. 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Motus GI Medical Technologies Ltd |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 ) | Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy. |
During the colonoscopy procedure withdrawal phase (10 min in average) | |
| Primary | Safety as Measured by Number of Serious Adverse Events and Major Complications. | Max of 9 days | ||
| Secondary | Percentage of Participants in Whom the Cecum Was Reached | A procedure was considered complete when the cecum was reached and visualized. | During the colonoscopy procedure |