Spots Global Cancer Trial Database for Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
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Trial Identification
Brief Title: Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
Official Title: Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
Study ID: NCT06305364
Interventions
Study Description
Brief Summary: This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Westside GI, New York, New York, United States
NewYork-Presbyterian / Columbia University Irving Medical Center, New York, New York, United States
Contact Details
Name: Daniella Bleistein
Affiliation: Jubaan Ltd.
Role: STUDY_DIRECTOR
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