Trial Outcomes & Findings for Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy (NCT NCT02161549)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

71 participants

Primary outcome timeframe

during colonoscopy procedure after cleansing with CleanUp System

Results posted on

2017-09-20

Participant Flow

The recruitment was done in two phases: Phase 1- under protocol Rev 1.0 used MotusGi CleanUp System Rev 1.0 , study period Aug- Jan 2012. 40 subjects enrolled. Phase 2- under protocol Rev 2.0 used MotusGi CleanUp System Rev 1.5 , study period Jul-Oct 2013.31 subjects enrolled.

Participant milestones

Participant milestones
Measure	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 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 Motus Gl CleanUp System
Overall Study STARTED	40	31
Overall Study COMPLETED	34	29
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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 Motus Gl CleanUp System
Overall Study Physician Decision	6	2

Baseline Characteristics

Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colonoscopy With MotusGi CleanUp System Rev 1.0 n=34 Participants subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System	Colonoscopy With MotusGi CleanUp System Rev 1.5 n=29 Participants subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System	Total n=63 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 3.8 • n=5 Participants	53 years STANDARD_DEVIATION 4.1 • n=7 Participants	54 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: during colonoscopy procedure after cleansing with CleanUp System

Population: the mean and standard deviation of the average score after cleansing the colon using the Motus 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

Outcome measures

Outcome measures
Measure	Colonoscopy With MotusGi CleanUp System Rev 1.0 n=34 Participants subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System	Colonoscopy With MotusGi CleanUp System Rev 1.5 n=29 Participants subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System	2.9 units on a scale Standard Deviation 0.4	2.9 units on a scale Standard Deviation 0.2

Adverse Events

Colonoscopy With MotusGi CleanUp System Rev 1.0

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Colonoscopy With MotusGi CleanUp System Rev 1.5

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Colonoscopy With MotusGi CleanUp System Rev 1.0 n=40 participants at risk subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System	Colonoscopy With MotusGi CleanUp System Rev 1.5 n=31 participants at risk subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System
Gastrointestinal disorders Erosion	12.5% 5/40 • Number of events 7	41.9% 13/31 • Number of events 13
Gastrointestinal disorders Hematoma	12.5% 5/40 • Number of events 11	22.6% 7/31 • Number of events 8
Gastrointestinal disorders Vesicles	7.5% 3/40 • Number of events 3	0.00% 0/31
Gastrointestinal disorders Laceration	0.00% 0/40	19.4% 6/31 • Number of events 6
Gastrointestinal disorders Papules	10.0% 4/40 • Number of events 5	0.00% 0/31

Additional Information

Ravit Peled -Director of Clinical Trial

MotusGI

Phone: +972 (0)4 6214447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place