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Completed

NCT Number: NCT02387268

Evaluation of the Performance of the CleanC System-Israel

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

Colorectal Cancer (CRC) Screening Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).

Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects in the age range of 18-75 years
  • Subjects with BMI within the range of 18.5-35
  • Subject is willing to sign informed consent form

Exclusion criteria

  • Active or severe inflammatory bowel disease (IBD)
  • Subjects with severe diverticulitis \\ diverticular disease (known or detected)
  • Known or detected colonic stenosis
  • Known or detected bowel obstruction
  • History of prior colon surgery
  • ASA≥IV (sever systemic disease)
  • Sever Renal insufficiency (Creatinine≥1.5mg%)
  • Sever Liver insufficiency (ALT/AST≥2UNL)
  • Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent
  • pregnancy
  • Subjects with altered mental status/inability to provide informed consent
  • Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly

Treatment and study plan

CleanC system

Device

Cleansing liquid and fecal matter during a standard colonoscopy procedure

Primary outcomes

  1. Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )

    Time frame: During the colonoscopy procedure withdrawal phase (10 min in average)

    Scale ranges- Min-0, Max-3 where:

    0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.

    • = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
    • = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
    • = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.

  2. Safety as Measured by Number of Serious Adverse Events and Major Complications.

    Time frame: Max of 9 days

Secondary outcomes

  1. Percentage of Participants in Whom the Cecum Was Reached

    Time frame: During the colonoscopy procedure

    A procedure was considered complete when the cecum was reached and visualized.

Sponsors and collaborators

Lead sponsor

Motus GI Medical Technologies Ltd

Industry

Registry information

Official study title

Evaluation of the Performance of the "CleanC" System

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
Sep 20, 2017

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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