NCT Number: NCT01838980
Evaluation of the Motus GI CleanUp System During Screening Colonoscopy
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.
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Notify MeKey information
Conditions
Age range
50 year–69 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
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 GI diseases or history of Colorectal cancer (personal or family)
- Previous major abdominal surgeries
- Medical status ASA grater or equal to 3
- Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
- 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
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Motus GI Medical Technologies Ltd
Industry
Registry information
Official study title
Evaluation of the Motus GI CleanUp System During Screening
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Apr 24, 2013
- Registry last updated
- Feb 14, 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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