Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

CRC Clinical Trial

Official title:

Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161549
• Other study ID #: CP-MCU-SP-1211
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: August 22, 2017
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2017
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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:

1. One head that irrigates and evacuates instead of two heads

2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.

3. System adjustment to the above changes including updated software version.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• CRC

Intervention

Device:
• Motus Gl CleanUp System

Locations

Country	Name	City	State
Spain	Clinica San Rafael	Cadiz

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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