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OpenTrials
Completed

NCT Number: NCT02572076

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

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.

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Key information

Conditions

CRC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HaEemek Medical Center

Afula, IL, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Motus Cleansing System

Device

Primary outcomes

  1. Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS

    Time frame: Within 24 hours- During the colonoscopy procedure

    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

Sponsors and collaborators

Lead sponsor

Motus GI Medical Technologies Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 8, 2015
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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