Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

NCT01838980 | Completed Results DMC

• 1 other identifier: CP-MCU-IL-0412
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CRC

Keywords

Colonoscopy Cleaning

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Colonoscopy

EXPERIMENTAL

Device: Motus GI Clean-Up Device

Interventions

Motus GI Clean-Up Device DEVICE

Colonoscopy

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

Results Point of Contact

• Title: Medical Consultant
• Organization: Motus GI Medical Technologies Ltd.

rose@motusgi.com

+972-4-6214446

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2013
• First Posted: April 24, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 14, 2017
• Results First Posted: May 13, 2014

Record last verified: 2014-04