NCT02572076

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 27, 2018

Completed
Last Updated

September 25, 2018

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

October 6, 2015

Results QC Date

December 4, 2017

Last Update Submit

August 26, 2018

Conditions

CRC

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Motus Cleansing System (MCS)

EXPERIMENTAL

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.

Device: Motus Cleansing System

Interventions

Motus Cleansing SystemDEVICE
Motus Cleansing System (MCS)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects being considered for diagnostic, screening or surveillance colonoscopy
  • Subjects in the age range of 18-75 years inclusive
  • Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive
  • Subject has signed the informed consent

You may not qualify if:

  • Subjects with known Inflammatory Bowel Disease
  • Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
  • Subjects with known or detected (during colonoscopy) bowel obstruction
  • History of prior surgery to colon and/or rectum
  • ASA≥IV
  • Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
  • Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
  • Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy
  • Pregnancy (as stated by patient) or breast feeding
  • Subjects with altered mental status/inability to provide informed consent
  • Patients who have participated in another interventional clinical study in the last 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEemek Medical Center

Afula, IL, Israel

Location

Results Point of Contact

Title
Ravit Peled -Director of Clinical Trial
Organization
Motus GI Medical Technologies Ltd.
ravit@motusgi.com
0733243823

Study Officials

  • Ian Gralnek, PHD

    HaEmek Medical Center, Afula Israel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

January 31, 2016

Primary Completion

December 26, 2016

Study Completion

November 26, 2017

Last Updated

September 25, 2018

Results First Posted

August 27, 2018

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)