Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System

CRC Clinical Trial

Official title:

Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572076
• Other study ID #: CL00035
• Status: Completed
• Phase: N/A
• Start date: January 31, 2016
• Est. completion date: November 26, 2017

Study information

• Verified date: December 2016
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

Description:

The main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 26, 2017
• Est. primary completion date: December 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 Body Mass 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) and dual anti-platelet therapy

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

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

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

Related Conditions & MeSH terms

• CRC

Intervention

Device:
• Motus Cleansing System

Locations

Country	Name	City	State
Israel	HaEemek Medical Center	`Afula	IL

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS	The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.; Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid.; Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well.; Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid.; subject consider as having adequate cleaning if BBPS>1 in all colon segments	Within 24 hours- During the colonoscopy procedure