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Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT02161549
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : June 15, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Motus GI Medical Technologies Ltd

Brief Summary:

Motus Gl 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
CRC Device: Motus Gl CleanUp System

Detailed Description:

63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.

40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:

  1. One head that irrigates and evacuates instead of two heads
  2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
  3. System adjustment to the above changes including updated software version.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
Actual Study Start Date : July 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Colonoscopy with MotusGi CleanUp System Rev 1.0
subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0
Device: Motus Gl CleanUp System
Colonoscopy with MotusGi CleanUp System Rev 1.5
subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0
Device: Motus Gl CleanUp System



Primary Outcome Measures :
  1. Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System [ Time Frame: during colonoscopy procedure after cleansing with CleanUp System ]
    Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System



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
Sampling Method:   Non-Probability Sample
Study Population
subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of G diseases or history of Colorectal cancer (personal or family)
  • Previous major abdominal surgeries
  • Medical status ASA grater or equal to 3
  • Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
  • Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
  • Life-threatening condition
  • Subjects who are unable or unwilling to cooperate with study procedures
  • Severe Diverticula

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161549


Locations
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Spain
Clinica San Rafael
Cadiz, Spain, 11002
Sponsors and Collaborators
Motus GI Medical Technologies Ltd
Additional Information:

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Responsible Party: Motus GI Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT02161549    
Other Study ID Numbers: CP-MCU-SP-1211
First Posted: June 11, 2014    Key Record Dates
Results First Posted: June 15, 2017
Last Update Posted: September 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No