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Evaluation of the Performance of the CleanC System-Israel

Primary Purpose

Colorectal Cancer (CRC) Screening

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CleanC system
Sponsored by
Motus GI Medical Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer (CRC) Screening

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Active or severe inflammatory bowel disease (IBD)
  2. Subjects with severe diverticulitis \ diverticular disease (known or detected)
  3. Known or detected colonic stenosis
  4. Known or detected bowel obstruction
  5. History of prior colon surgery
  6. ASA≥IV (sever systemic disease)
  7. Sever Renal insufficiency (Creatinine≥1.5mg%)
  8. Sever Liver insufficiency (ALT/AST≥2UNL)
  9. Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent
  10. pregnancy
  11. Subjects with altered mental status/inability to provide informed consent
  12. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CleanC

    Arm Description

    Standard colonoscopy procedure using the CleanC system

    Outcomes

    Primary Outcome Measures

    Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
    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.
    Safety as Measured by Number of Serious Adverse Events and Major Complications.

    Secondary Outcome Measures

    Percentage of Participants in Whom the Cecum Was Reached
    A procedure was considered complete when the cecum was reached and visualized.

    Full Information

    First Posted
    March 2, 2015
    Last Updated
    August 22, 2017
    Sponsor
    Motus GI Medical Technologies Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02387268
    Brief Title
    Evaluation of the Performance of the CleanC System-Israel
    Official Title
    Evaluation of the Performance of the "CleanC" System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Motus GI Medical Technologies Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer (CRC) Screening

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CleanC
    Arm Type
    Experimental
    Arm Description
    Standard colonoscopy procedure using the CleanC system
    Intervention Type
    Device
    Intervention Name(s)
    CleanC system
    Intervention Description
    Cleansing liquid and fecal matter during a standard colonoscopy procedure
    Primary Outcome Measure Information:
    Title
    Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
    Description
    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.
    Time Frame
    During the colonoscopy procedure withdrawal phase (10 min in average)
    Title
    Safety as Measured by Number of Serious Adverse Events and Major Complications.
    Time Frame
    Max of 9 days
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants in Whom the Cecum Was Reached
    Description
    A procedure was considered complete when the cecum was reached and visualized.
    Time Frame
    During the colonoscopy procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    De-identified individual participant for primary and secondary outcome measures may be become available in the future

    Learn more about this trial

    Evaluation of the Performance of the CleanC System-Israel

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