Evaluation of the Performance of the CleanC System-Israel

Not Applicable

Completed

• Conditions: Colorectal Cancer (CRC) Screening
• Interventions: Device: CleanC system

• Registration Number: NCT02387268
• Lead Sponsor: Motus GI Medical Technologies Ltd

Brief 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.

Detailed Description

The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).

Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.

Study Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-08
• Study First Posted: 2015-03-12
• Study Start: 2015-05
• Primary Completion: 2015-06
• Results First Submitted: 2015-10-06
• Study Completion: 2015-11
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-08
• Results First Posted: 2016-03-07
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CleanC	CleanC system	Standard colonoscopy procedure using the CleanC system

Primary Outcome Measures

Name	Time	Method
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )	During the colonoscopy procedure withdrawal phase (10 min in average)	Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.; 1. = 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.; 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.; 3. = 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.
Safety as Measured by Number of Serious Adverse Events and Major Complications.	Max of 9 days

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in Whom the Cecum Was Reached	During the colonoscopy procedure	A procedure was considered complete when the cecum was reached and visualized.