Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing 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: CRC
• Intervention / Treatment: Device: Motus Cleansing System

Detailed Description

The main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy

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

Contacts and Locations

Study Locations

• Israel
  • IL
    • 'Afula, IL, Israel
      • HaEemek Medical Center

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 being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria:

1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA≥IV
6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy
9. Pregnancy (as stated by patient) or breast feeding
10. Subjects with altered mental status/inability to provide informed consent
11. Patients who have participated in another interventional clinical study in the last 2 months

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: Motus Cleansing System (MCS); The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.

Device: Motus Cleansing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS	The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS>1 in all colon segments	Within 24 hours- During the colonoscopy procedure

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd
• Investigators: Principal Investigator: Ian Gralnek, PHD, HaEmek Medical Center, Afula Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2016
• Primary Completion (Actual): December 26, 2016
• Study Completion (Actual): November 26, 2017

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: August 26, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CL00035

Plan for Individual participant data (IPD)

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