Evaluation of the Performance of the CleanC System-Israel

Evaluation of the Performance of the "CleanC" System

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer (CRC) Screening
• Intervention / Treatment: Device: CleanC system

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CleanC; Standard colonoscopy procedure using the CleanC system	Device: CleanC system; Cleansing liquid and fecal matter during a standard colonoscopy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Safety as Measured by Number of Serious Adverse Events and Major Complications.		Max of 9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 8, 2015
• First Posted (Estimate): March 12, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CL00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participant for primary and secondary outcome measures may be become available in the future

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No