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

CRC Clinical Trial

— MCS  

Official title:

Evaluation of the Performance of the Motus Cleansing System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026075
• Other study ID #: CL00016
• Status: Completed
• Phase: N/A
• Start date: December 22, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: June 2017
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• 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 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

Related Conditions & MeSH terms

• CRC

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of MCS in Cleansing a Poorly Prepared Colon.	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.	Up to 2 hours