Trial Outcomes & Findings for Evaluation of the Motus GI CleanUp System During Screening Colonoscopy (NCT NCT01838980)

Results Overview

Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be \>=2.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Following the colonoscopic procedure- Up to 24 hours.

Results posted on

2017-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Colonoscopy Motus GI Clean-Up Device
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colonoscopy n=15 Participants Motus GI Clean-Up Device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Gender Female	8 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Following the colonoscopic procedure- Up to 24 hours.

Population: 15 subjects were enrolled to the study. 1 was excluded. Total of 14 subjects were analyzed.

Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be \>=2.

Outcome measures

Outcome measures
Measure	Colonoscopy n=14 Participants Motus GI Clean-Up Device
Mean of All Subjects Colon Segments BBPS>=2	3 Mean of BBPS score per segment Standard Deviation 0

Adverse Events

Colonoscopy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Colonoscopy n=15 participants at risk Motus GI Clean-Up Device
Gastrointestinal disorders Mild Abdominal bloating	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Mild mucosal bruising	26.7% 4/15 • Number of events 7
Cardiac disorders Bradycardia	6.7% 1/15 • Number of events 1

Additional Information

Medical Consultant

Motus GI Medical Technologies Ltd.

Phone: +972-4-6214446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60