Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
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|ClinicalTrials.gov Identifier: NCT02161549|
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : June 15, 2017
Last Update Posted : September 20, 2017
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.
|Condition or disease||Intervention/treatment|
|CRC||Device: Motus Gl CleanUp System|
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:
- One head that irrigates and evacuates instead of two heads
- Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
- System adjustment to the above changes including updated software version.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||71 participants|
|Target Follow-Up Duration:||2 Days|
|Official Title:||Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy|
|Actual Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Colonoscopy with MotusGi CleanUp System Rev 1.0
subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0
Device: Motus Gl CleanUp System
Colonoscopy with MotusGi CleanUp System Rev 1.5
subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Device: Motus Gl CleanUp System
- Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System [ Time Frame: during colonoscopy procedure after cleansing with 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161549
|Clinica San Rafael|
|Cadiz, Spain, 11002|