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Brief Title: Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Official Title: Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Study ID: NCT05275556
Brief Summary: This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.
Detailed Description:
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Mayo Clinic, Rochester, Minnesota, United States
Duke Health, Durham, North Carolina, United States
Great Lakes Gastroenterology Research, Mentor, Ohio, United States
Susquehanna Research Group, Camp Hill, Pennsylvania, United States
ANRC Research, El Paso, Texas, United States
Elisha Medical Center, Haifa, , Israel
Sourasky Medical Center (Ichilov), Tel Aviv, , Israel
Name: Scooter Plowman, MD
Affiliation: Verily Life Sciences LLC
Role: STUDY_DIRECTOR