Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

NCT ID: NCT01838980

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Colonoscopy

Group Type: EXPERIMENTAL

Motus GI Clean-Up Device

Intervention Type: DEVICE

Interventions

Motus GI Clean-Up Device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Motus GI Medical Technologies Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CP-MCU-IL-0412

Identifier Type: -

Identifier Source: org_study_id