Evaluation of the Performance of the Motus Cleansing System (MCS)

• Sponsor: Motus GI Medical Technologies Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03026075
• Collaborator: (none)
• Enrollment: 47
• Locations: 3
• Arm: 1
• Actual Duration (Months): 5.3
• Patients Per Site: 15.7
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.

Condition or Disease	Intervention/Treatment	Phase
CRC	Device: Motus Cleansing System (MCS)	N/A

Detailed Description

Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands).

Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure.

Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Evaluation of the Performance of the Motus Cleansing System
• Actual Study Start Date: Dec 22, 2016
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Colonoscopy with MCS Standard colonoscopy procedure with Motus Cleansing System

Device: 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.

Outcome Measures

Primary Outcome Measures

1. Performance of MCS in Cleansing a Poorly Prepared Colon. [Up to 2 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subjects being considered for diagnostic, screening or surveillance colonoscopy

2. Subjects in the age range of 18-75 years inclusive

3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive

4. Subject has signed the informed consent

Exclusion Criteria:

1. Subjects with known Inflammatory Bowel Disease

2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease

3. Subjects with known or detected (during colonoscopy) bowel obstruction

4. History of prior surgery to colon and/or rectum

5. ASA≥IV

6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)

7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)

8. Subjects taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy

9. Subjects with known coagulation disorder (INR >1.5).

10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl

11. Subjects with active, ongoing lower GI bleeding with hemodynamic instability.

12. Subjects with known Mega Colon

13. Pregnancy (as stated by patient) or breast feeding

14. Subjects with altered mental status/inability to provide informed consent

15. Patients who have participated in another interventional clinical study in the last 2 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMC Of JOHANNES GUTENBERG-UNIVERSITY MAINZ	Mainz		Germany
2	University Medical Centre (UMC) Radboud Department of Gastroenterology and Hepatology	Nijmegen		Netherlands
3	Erasmus medical center	Rotterdam		Netherlands

Sponsors and Collaborators

• Motus GI Medical Technologies Ltd

Investigators

• Study Director: Ravit Peled, Motus GI Technologies Ltd.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 27, 2016

More Information

Publications

None provided.

• Responsible Party: Motus GI Medical Technologies Ltd
• ClinicalTrials.gov Identifier: NCT03026075
• Other Study ID Numbers: CL00016
• First Posted: Jan 20, 2017
• Last Update Posted: Feb 11, 2019
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

Participant Flow

Recruitment Details	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
Pre-assignment Detail	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).

Arm/Group Title	Colonoscopy With MCS
Arm/Group Description	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.
Period Title: Overall Study
STARTED	47
COMPLETED	46
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Colonoscopy With MCS
Arm/Group Description	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.
Overall Participants	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.9 (11.8)
Sex: Female, Male (Count of Participants)
Female	27 57.4%
Male	20 42.6%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	44 93.6%
Hispanic	2 4.3%
Asian	1 2.1%
Region of Enrollment (participants) [Number]
Netherlands	32 68.1%
Germany	15 31.9%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.0 (4.0)

Outcome Measures

1. Primary Outcome

Title	Performance of MCS in Cleansing a Poorly Prepared Colon.
Description	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.
Time Frame	Up to 2 hours

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Colonoscopy With MCS
Arm/Group Description	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.
Measure Participants	46
adequate cleaning after the use of MCS	46 97.9%
adequate cleaning at baseline	9 19.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colonoscopy With MCS
	Comments	The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon. A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions: Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	McNemar
	Comments

Adverse Events

Time Frame	Follow up was conducted immediately after the procedure before patient discharge and at 2-3 days and 14-16 days post procedure
Arm/Group Title	Colonoscopy With MCS
Arm/Group Description	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.
All Cause Mortality
	Colonoscopy With MCS
	Affected / at Risk (%)	# Events
Total	0/47 (0%)
Serious Adverse Events
	Colonoscopy With MCS
	Affected / at Risk (%)	# Events
Total	0/47 (0%)
Other (Not Including Serious) Adverse Events
	Colonoscopy With MCS
	Affected / at Risk (%)	# Events
Total	5/47 (10.6%)
Gastrointestinal disorders
Bloating	5/47 (10.6%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.