NCT02161549

Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Motus GI Medical Technologies Ltd · Industry
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• CRC

Interventions

Type	Name	Description
DEVICE	Motus Gl CleanUp System

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2014-06-11
• Last updated: 2017-09-20
• Results posted: 2017-06-15

Locations

1 site across 1 country: Spain