Trial Outcomes & Findings for Evaluation of the Performance of the Motus Cleansing System (MCS) (NCT NCT03026075)
NCT ID: NCT03026075
Last Updated: 2019-02-11
Results Overview
The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.
COMPLETED
NA
47 participants
Up to 2 hours
2019-02-11
Participant Flow
patients indicated for screening/ surveillance or diagnosis colonoscopy enrolled at 3 clinical sites as follows: * Radboud University Medical Center(UMC)- Netherlands-16 cases * Erasmus Medical Center (MC)-Netherlands-16 cases * Mainz University Medical Center(UMC)-Germany- 15 cases enrollment period : 20 December 2016 - 31 May 2017
The patients had reduced preparation in order to mimic poor bowel cleansing. the study bowel preparation consisted of dietary restrictions (no dried fruit, seeds or nuts) starting 2 days prior to colonoscopy, a 24-hour clear liquid diet and a split dose of 20 mg Bisacodyl (10 mg in each dose).
Participant milestones
| Measure |
Colonoscopy With MCS
Standard colonoscopy procedure with Motus Cleansing System
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
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|---|---|
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Overall Study
STARTED
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47
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Overall Study
COMPLETED
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46
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Colonoscopy With MCS
Standard colonoscopy procedure with Motus Cleansing System
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
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|---|---|
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Evaluation of the Performance of the Motus Cleansing System (MCS)
Baseline characteristics by cohort
| Measure |
Colonoscopy With MCS
n=47 Participants
Standard colonoscopy procedure with Motus Cleansing System
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
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|---|---|
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Age, Continuous
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56.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
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Sex: Female, Male
Female
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27 Participants
n=5 Participants
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Sex: Female, Male
Male
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20 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · White Non-Hispanic
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44 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Hispanic
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Asian
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1 Participants
n=5 Participants
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Region of Enrollment
Netherlands
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32 participants
n=5 Participants
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Region of Enrollment
Germany
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15 participants
n=5 Participants
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Body Mass Index (BMI)
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26.0 kg/m^2
STANDARD_DEVIATION 4.0 • n=5 Participants
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PRIMARY outcome
Timeframe: Up to 2 hoursPopulation: the bowel preparation level before and after the use of Motus Cleansing System was evaluated using the Boston Bowel Preparation Scale (BBPS) where patients consider to have adequate cleansing level if all 3 colon segments graded 2 or 3 ( good or excellent)
The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.
Outcome measures
| Measure |
Colonoscopy With MCS
n=46 Participants
Standard colonoscopy procedure with Motus Cleansing System
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
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|---|---|
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Performance of MCS in Cleansing a Poorly Prepared Colon.
adequate cleaning after the use of MCS
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46 Participants
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Performance of MCS in Cleansing a Poorly Prepared Colon.
adequate cleaning at baseline
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9 Participants
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Adverse Events
Colonoscopy With MCS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colonoscopy With MCS
n=47 participants at risk
Standard colonoscopy procedure with Motus Cleansing System
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter \& fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
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|---|---|
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Gastrointestinal disorders
Bloating
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10.6%
5/47 • Number of events 5 • Follow up was conducted immediately after the procedure before patient discharge and at 2-3 days and 14-16 days post procedure
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Additional Information
Ravit Peled -Director of Clinical Trial
Motus GI Medical Technologies Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place