Trial Outcomes & Findings for Evaluation of the Performance of the CleanC System-Israel (NCT NCT02387268)

Results Overview

Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

During the colonoscopy procedure withdrawal phase (10 min in average)

Results posted on

2017-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	CleanC Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Performance of the CleanC System-Israel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CleanC n=10 Participants Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Israel	10 participants n=5 Participants

PRIMARY outcome

Timeframe: During the colonoscopy procedure withdrawal phase (10 min in average)

Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.

Outcome measures

Outcome measures
Measure	CleanC n=9 Participants Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )	88.9 percentage of participants Interval 51.7 to 99.7

PRIMARY outcome

Timeframe: Max of 9 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the colonoscopy procedure

A procedure was considered complete when the cecum was reached and visualized.

Outcome measures

Outcome measures
Measure	CleanC n=9 Participants Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure
Percentage of Participants in Whom the Cecum Was Reached	88.9 percentage of participants Interval 51.7 to 99.7

Adverse Events

CleanC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CleanC n=10 participants at risk Standard colonoscopy procedure using the CleanC system CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure
Gastrointestinal disorders Mild abdominal pain	10.0% 1/10 • Number of events 1

Additional Information

Dr.Kobie Dickstein

M.C.Carmel

Phone: 048250055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place