Evaluation of the Performance of the Motus Cleansing System (MSC)

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy Procedure
• Intervention / Treatment: Device: Motus Cleansing System

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 Type: Interventional
• Enrollment (Actual): 47
• 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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motus CleanC System; Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0	Device: Motus Cleansing System; Other Names: Motus CleanC
Experimental: Motus Cleansing System Rev 2.5; Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0	Device: Motus Cleansing System; Other Names: Motus CleanC
Experimental: Motus Cleansing System Rev 3.0; Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0	Device: Motus Cleansing System; Other Names: Motus CleanC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem	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.	Following the colonoscopic procedure- Up to 24 hours.

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CP-MCC-SA-0214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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