Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
1 other identifier
observational
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedResults Posted
Study results publicly available
June 15, 2017
CompletedSeptember 20, 2017
March 1, 2017
1.3 years
June 10, 2014
March 29, 2017
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI 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
during colonoscopy procedure after cleansing with CleanUp System
Study Arms (2)
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
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
Interventions
Eligibility Criteria
subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica San Rafael
Cadiz, 11002, Spain
Results Point of Contact
- Title
- Ravit Peled -Director of Clinical Trial
- Organization
- MotusGI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 11, 2014
Study Start
July 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
September 20, 2017
Results First Posted
June 15, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share