Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

Completed

• Conditions: CRC
• Interventions: Device: Motus Gl CleanUp System

• Registration Number: NCT02161549
• Lead Sponsor: Motus GI Medical Technologies Ltd

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Status Verified: 2017-03
• Results First Submitted: 2017-03-29
• Results First Submitted QC: 2017-03-29
• Results First Posted: 2017-06-15
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colonoscopy with MotusGi CleanUp System Rev 1.5	Motus Gl CleanUp System	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Colonoscopy with MotusGi CleanUp System Rev 1.0	Motus Gl CleanUp System	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0

Primary Outcome Measures

Name	Time	Method
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System	during colonoscopy procedure after cleansing with 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

Trial Locations

Locations (1)

Clinica San Rafael; 🇪🇸 Cadiz, Spain