NCT03026075

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

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

Study Start

First participant enrolled

December 22, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 11, 2019

Completed
Last Updated

February 11, 2019

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

January 17, 2017

Results QC Date

December 27, 2017

Last Update Submit

September 25, 2018

Conditions

CRC

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Colonoscopy with MCS

EXPERIMENTAL

Standard colonoscopy procedure with Motus Cleansing System

Device: Motus Cleansing System (MCS)

Interventions

Motus Cleansing System (MCS)DEVICE

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.

Colonoscopy with 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 BodyMass 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) or dual antiplatelet therapy
  • Subjects with known coagulation disorder (INR \>1.5).
  • Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
  • Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
  • Subjects with known Mega Colon
  • 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 (3)

UMC Of JOHANNES GUTENBERG-UNIVERSITY MAINZ

Mainz, Germany

Location

University Medical Centre (UMC) Radboud Department of Gastroenterology and Hepatology

Nijmegen, Netherlands

Location

Erasmus medical center

Rotterdam, Netherlands

Location

Related Publications (1)

  • van Keulen KE, Neumann H, Schattenberg JM, van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.

    PMID: 29996152DERIVED

Results Point of Contact

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

Study Officials

  • Ravit Peled

    Motus GI Technologies Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

January 17, 2017

First Posted

January 20, 2017

Study Start

December 22, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

February 11, 2019

Results First Posted

February 11, 2019

Record last verified: 2017-06

Locations

NL(2)DE(1)