Evaluation of the Performance of the Motus Cleansing System

Not Applicable

Completed

• Conditions: Colonoscopy Procedure

• Registration Number: NCT02161536
• Lead Sponsor: Motus GI Medical Technologies Ltd

Brief Summary

The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.

Detailed Description

Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4\*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.

following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Study Start: 2014-07
• Primary Completion: 2016-04
• Status Verified: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2017-03-29
• Results First Submitted QC: 2018-03-20
• Last Update Submitted: 2018-03-20
• Results First Posted: 2018-11-06
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 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
• Sever Liver insufficiency
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem	Following the colonoscopic procedure- Up to 24 hours.	The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2) .; Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.