Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

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

Official Title
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Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

Conditions
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CRC

Intervention / Treatment
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* Device: Motus Gl CleanUp System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy with MotusGi CleanUp System Rev 1.0<br>subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 | Device: Motus Gl CleanUp System<br> <br> |
| Colonoscopy with MotusGi CleanUp System Rev 1.5<br>subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 | Device: Motus Gl CleanUp System<br> <br> |

What is the study measuring?
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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 |