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OpenTrials
Completed

NCT Number: NCT02161549

Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

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.

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Key information

Conditions

CRC

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica San Rafael

Cadiz, 11002, Spain

About this study

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:

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

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 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

Treatment and study plan

Motus Gl CleanUp System

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Motus GI Medical Technologies Ltd

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2014
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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