Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

• Sponsor: Motus GI Medical Technologies Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01838980
• Collaborator: (none)
• Enrollment: 15
• Arm: 1
• Duration (Months): 10.1

Study Details

Study Description

Brief Summary

Motus GI 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 GI Clean-Up Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Evaluation of the Motus GI CleanUp System During Screening
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colonoscopy	Device: Motus GI Clean-Up Device

Outcome Measures

Primary Outcome Measures

1. Mean of All Subjects Colon Segments BBPS>=2 [Following the colonoscopic procedure- Up to 24 hours.]

   Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subjects in the age range of 50-69 years

2. Subjects who are considered for routine screening colonoscopy

3. Subjects with BMI within the range of 18.5-30

4. Subject is willing to sign informed consent form

Exclusion Criteria:

1. History of GI diseases or history of Colorectal cancer (personal or family)

2. Previous major abdominal surgeries

3. Medical status ASA grater or equal to 3

4. Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).

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

6. Life-threatening condition

7. Subjects who are unable or unwilling to cooperate with study procedures

8. Severe Diverticula

Contacts and Locations

Locations

No locations specified.

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: NCT01838980
• Other Study ID Numbers: CP-MCU-IL-0412
• First Posted: Apr 24, 2013
• Last Update Posted: Feb 14, 2017
• Last Verified: Apr 1, 2014

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Motus GI Medical Technologies Ltd: Colonoscopy Cleaning

Study Results

Participant Flow

Arm/Group Title	Colonoscopy
Arm/Group Description	Motus GI Clean-Up Device
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Colonoscopy
Arm/Group Description	Motus GI Clean-Up Device
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 86.7%
>=65 years	2 13.3%
Gender (Count of Participants)
Female	8 53.3%
Male	7 46.7%

Outcome Measures

1. Primary Outcome

Title	Mean of All Subjects Colon Segments BBPS>=2
Description	Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2.
Time Frame	Following the colonoscopic procedure- Up to 24 hours.

Outcome Measure Data

Analysis Population Description

15 subjects were enrolled to the study. 1 was excluded. Total of 14 subjects were analyzed.

Arm/Group Title	Colonoscopy
Arm/Group Description	Motus GI Clean-Up Device
Measure Participants	14
Mean (Standard Deviation) [Mean of BBPS score per segment]	3 (0)

Adverse Events

Arm/Group Title	Colonoscopy
Arm/Group Description	Motus GI Clean-Up Device
All Cause Mortality
	Colonoscopy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Colonoscopy
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Colonoscopy
	Affected / at Risk (%)	# Events
Total	6/15 (40%)
Cardiac disorders
Bradycardia	1/15 (6.7%)	1
Gastrointestinal disorders
Mild Abdominal bloating	1/15 (6.7%)	1
Mild mucosal bruising	4/15 (26.7%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.