Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

Not Applicable

Completed

• Conditions: CRC
• Interventions: Device: Motus GI Clean-Up Device

• Registration Number: NCT01838980
• Lead Sponsor: Motus GI Medical Technologies Ltd

Brief Summary

Motus GI 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

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-21
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2014-02-04
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-13
• Results First Posted: 2014-05-13
• Last Update Submitted: 2016-12-26
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonoscopy	Motus GI Clean-Up Device	-

Primary Outcome Measures

Name	Time	Method
Mean of All Subjects Colon Segments BBPS>=2	Following the colonoscopic procedure- Up to 24 hours.	Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).; Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be \>=2.