Evaluation of the Performance of the CleanC System-Israel

Motus GI Medical Technologies Ltd10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Colorectal Cancer (CRC) Screening

Interventions

CleanC systemDEVICE

Cleansing liquid and fecal matter during a standard colonoscopy procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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. 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.

Time frame: During the colonoscopy procedure withdrawal phase (10 min in average)

Safety as Measured by Number of Serious Adverse Events and Major Complications.

Time frame: Max of 9 days

Secondary Outcomes

Percentage of Participants in Whom the Cecum Was Reached

A procedure was considered complete when the cecum was reached and visualized.

Time frame: During the colonoscopy procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.