Trial Outcomes & Findings for Evaluation of the Performance of the Motus Cleansing System (NCT NCT02161536)

Results Overview

The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2) . Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Following the colonoscopic procedure- Up to 24 hours.

Results posted on

2018-11-06

Participant Flow

The study was conducted in 3 phases: Phase 1 - enrolled 6 subjects using Rev 2.0 of the device Phase 2 - enrolled 21 subjects using Rev 2.5 of the device Phase 3 - enrolled 20 subjects using Rev 3.0 of the device

Patients had to follow a specific bowel preparation in order to mimic poor bowel preparation: Arm 1: start clear liquid diet 24 hours prior to the procedure Arm 2: start clear liquid diet 24 hours prior to the procedure Arm 3: start clear liquid diet 18 hours prior to the procedure along with 4 tables of 5 mg Bisacodyl in split dose

Participant milestones

Participant milestones
Measure	Motus CleanC Syetem Rev 2.0 6 subjects used the second version of the device	Motus Cleansing System Rev 2.5 21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5	Motus Cleansing System Rev 3.0 20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0
Overall Study STARTED	6	21	20
Overall Study COMPLETED	6	21	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Performance of the Motus Cleansing System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motus CleanC System Rev 2.0 n=6 Participants Motus CleanC System Rev 2.0	Motus Cleansing System Rev 2.5 n=21 Participants Motus Cleansing System Rev 2.5	Motus Cleansing System Rev 3.0 n=20 Participants Motus Cleansing System Rev 3.0	Total n=47 Participants Total of all reporting groups
Age, Continuous	48 YEARS STANDARD_DEVIATION 8.7 • n=5 Participants	49.2 YEARS STANDARD_DEVIATION 11.6 • n=7 Participants	54.7 YEARS STANDARD_DEVIATION 6.6 • n=5 Participants	51.4 YEARS STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

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

Population: subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2)

The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2) . Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.

Outcome measures

Outcome measures
Measure	Motus CleanC System n=6 Participants Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0 Motus Cleansing System	Motus Cleansing System Rev 2.5 n=21 Participants Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0 Motus Cleansing System	Motus Cleansing System Rev 3.0 n=20 Participants Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0 Motus Cleansing System
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem	6 Participants	20 Participants	20 Participants

Adverse Events

Motus CleanC Syetem Rev 2.0

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Motus Cleansing System Rev 2.5

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Motus Cleansing System Rev 3.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Motus CleanC Syetem Rev 2.0 n=6 participants at risk 6 subjects used the second version of the device	Motus Cleansing System Rev 2.5 n=21 participants at risk 21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5	Motus Cleansing System Rev 3.0 n=20 participants at risk 20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0
Gastrointestinal disorders Bowel perforation	16.7% 1/6 • Number of events 1	0.00% 0/21	0.00% 0/20

Other adverse events

Other adverse events
Measure	Motus CleanC Syetem Rev 2.0 n=6 participants at risk 6 subjects used the second version of the device	Motus Cleansing System Rev 2.5 n=21 participants at risk 21 subjects enrolled under protocol Rev 4.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 2.5	Motus Cleansing System Rev 3.0 n=20 participants at risk 20 subjects enrolled under protocol Rev 5.0 , had a standard colonoscopy procedure with Motus Cleansing System Rev 3.0
Gastrointestinal disorders Laceration	33.3% 2/6 • Number of events 2	4.8% 1/21 • Number of events 1	0.00% 0/20
Gastrointestinal disorders Erosion	33.3% 2/6 • Number of events 2	0.00% 0/21	0.00% 0/20
Gastrointestinal disorders Submucosal Hematoma	33.3% 2/6 • Number of events 2	4.8% 1/21 • Number of events 1	0.00% 0/20

Additional Information

Ravit Peled -Director of Clinical Trial

Motus GI Medical Technologies Ltd.

Phone: +972 526145354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place