Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

Evaluation of the Motus GI CleanUp System During Screening

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.

Study Overview

• Status: Completed
• Conditions: CRC
• Intervention / Treatment: Device: Motus GI Clean-Up Device

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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: Colonoscopy	Device: Motus GI Clean-Up Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of All Subjects Colon Segments BBPS>=2	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.	Following the colonoscopic procedure- Up to 24 hours.

Collaborators and Investigators

• Sponsor: Motus GI Medical Technologies Ltd

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 21, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: December 26, 2016
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Colonoscopy Cleaning
• Other Study ID Numbers: CP-MCU-IL-0412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures may be made available in the future