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Evaluation of the Motus GI CleanUp System During Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT01838980
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : May 13, 2014
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Motus GI Medical Technologies Ltd

Study Description
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Brief Summary:
Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure. The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

Condition or disease Intervention/treatment Phase
CRC Device: Motus GI Clean-Up Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of the Motus GI CleanUp System During Screening
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Colonoscopy Device: Motus GI Clean-Up Device


Outcome Measures
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Primary Outcome Measures :
  1. Mean of All Subjects Colon Segments BBPS>=2 [ Time Frame: Following the colonoscopic procedure- Up to 24 hours. ]

    Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).

    Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects in the age range of 50-69 years
  2. Subjects who are considered for routine screening colonoscopy
  3. Subjects with BMI within the range of 18.5-30
  4. Subject is willing to sign informed consent form

Exclusion Criteria:

  1. History of GI diseases or history of Colorectal cancer (personal or family)
  2. Previous major abdominal surgeries
  3. Medical status ASA grater or equal to 3
  4. Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
  5. Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
  6. Life-threatening condition
  7. Subjects who are unable or unwilling to cooperate with study procedures
  8. Severe Diverticula
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Motus GI Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT01838980    
Other Study ID Numbers: CP-MCU-IL-0412
First Posted: April 24, 2013    Key Record Dates
Results First Posted: May 13, 2014
Last Update Posted: February 14, 2017
Last Verified: April 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified individual participant data for all primary and secondary outcome measures may be made available in the future
Keywords provided by Motus GI Medical Technologies Ltd:
Colonoscopy Cleaning