Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

• Sponsor: Motus GI Medical Technologies Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02161549
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.

The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

Condition or Disease	Intervention/Treatment	Phase
CRC	Device: Motus Gl CleanUp System

Detailed Description

63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.

40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:

1. One head that irrigates and evacuates instead of two heads

2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.

3. System adjustment to the above changes including updated software version.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 71 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Colonoscopy with MotusGi CleanUp System Rev 1.0 subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0	Device: Motus Gl CleanUp System
Colonoscopy with MotusGi CleanUp System Rev 1.5 subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0	Device: Motus Gl CleanUp System

Outcome Measures

Primary Outcome Measures

1. Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System [during colonoscopy procedure after cleansing with CleanUp System]

   Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects in the age range of 50-69 years

• Subjects who are considered for routine screening colonoscopy

• Subjects with BMI within the range of 18.5-30

• Subject is willing to sign informed consent form

Exclusion Criteria:

• History of G diseases or history of Colorectal cancer (personal or family)

• Previous major abdominal surgeries

• Medical status ASA grater or equal to 3

• Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).

• Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)

• Life-threatening condition

• Subjects who are unable or unwilling to cooperate with study procedures

• Severe Diverticula

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica San Rafael	Cadiz		Spain	11002

Sponsors and Collaborators

• Motus GI Medical Technologies Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Motus GI Medical Technologies Ltd
• ClinicalTrials.gov Identifier: NCT02161549
• Other Study ID Numbers: CP-MCU-SP-1211
• First Posted: Jun 11, 2014
• Last Update Posted: Sep 20, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	The recruitment was done in two phases: Phase 1- under protocol Rev 1.0 used MotusGi CleanUp System Rev 1.0 , study period Aug- Jan 2012. 40 subjects enrolled. Phase 2- under protocol Rev 2.0 used MotusGi CleanUp System Rev 1.5 , study period Jul-Oct 2013.31 subjects enrolled.

Arm/Group Title	Colonoscopy With MotusGi CleanUp System Rev 1.0	Colonoscopy With MotusGi CleanUp System Rev 1.5
Arm/Group Description	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System
Period Title: Overall Study
STARTED	40	31
COMPLETED	34	29
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Colonoscopy With MotusGi CleanUp System Rev 1.0	Colonoscopy With MotusGi CleanUp System Rev 1.5	Total
Arm/Group Description	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System	Total of all reporting groups
Overall Participants	34	29	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (3.8)	53 (4.1)	54 (4.0)
Sex: Female, Male (Count of Participants)
Female	13 38.2%	14 48.3%	27 42.9%
Male	21 61.8%	15 51.7%	36 57.1%

Outcome Measures

1. Primary Outcome

Title	Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System
Description	Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System
Time Frame	during colonoscopy procedure after cleansing with CleanUp System

Outcome Measure Data

Analysis Population Description

the mean and standard deviation of the average score after cleansing the colon using the Motus CleanUp System

Arm/Group Title	Colonoscopy With MotusGi CleanUp System Rev 1.0	Colonoscopy With MotusGi CleanUp System Rev 1.5
Arm/Group Description	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System
Measure Participants	34	29
Mean (Standard Deviation) [units on a scale]	2.9 (0.4)	2.9 (0.2)

Adverse Events

Arm/Group Title	Colonoscopy With MotusGi CleanUp System Rev 1.0		Colonoscopy With MotusGi CleanUp System Rev 1.5
Arm/Group Description	subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0 Motus Gl CleanUp System		subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0 Motus Gl CleanUp System
All Cause Mortality
	Colonoscopy With MotusGi CleanUp System Rev 1.0		Colonoscopy With MotusGi CleanUp System Rev 1.5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/31 (0%)
Serious Adverse Events
	Colonoscopy With MotusGi CleanUp System Rev 1.0		Colonoscopy With MotusGi CleanUp System Rev 1.5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Colonoscopy With MotusGi CleanUp System Rev 1.0		Colonoscopy With MotusGi CleanUp System Rev 1.5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/40 (42.5%)		17/31 (54.8%)
Gastrointestinal disorders
Erosion	5/40 (12.5%)	7	13/31 (41.9%)	13
Hematoma	5/40 (12.5%)	11	7/31 (22.6%)	8
Vesicles	3/40 (7.5%)	3	0/31 (0%)	0
Laceration	0/40 (0%)	0	6/31 (19.4%)	6
Papules	4/40 (10%)	5	0/31 (0%)	0

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.