Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.

The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

Study Overview

• Status: Completed
• Conditions: CRC
• Intervention / Treatment: Device: Motus Gl CleanUp System

Detailed Description

63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.

40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:

1. One head that irrigates and evacuates instead of two heads
2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
3. System adjustment to the above changes including updated software version.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Spain
  • Cadiz, Spain, 11002
    • Clinica San Rafael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)

Description

Inclusion Criteria:

• Subjects in the age range of 50-69 years
• Subjects who are considered for routine screening colonoscopy
• Subjects with BMI within the range of 18.5-30
• Subject is willing to sign informed consent form

Exclusion Criteria:

• History of G diseases or history of Colorectal cancer (personal or family)
• Previous major abdominal surgeries
• Medical status ASA grater or equal to 3
• Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
• Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
• Life-threatening condition
• Subjects who are unable or unwilling to cooperate with study procedures
• Severe Diverticula

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colonoscopy with MotusGi CleanUp System Rev 1.0; subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0	Device: Motus Gl CleanUp System
Colonoscopy with MotusGi CleanUp System Rev 1.5; subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0	Device: Motus Gl CleanUp System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System	Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System	during colonoscopy procedure after cleansing with CleanUp System

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

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): September 20, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CP-MCU-SP-1211

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