Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-001278
NCT ID: NCT05275556
Sponsor Protocol Number: 103820
About this study
The purpose of this research is to evaluate the accuracy of a medical device that has been developed to automatically find polyps (small growths) during colonoscopies. The device uses a computer to detect and highlight potential polyps from the usual video images made during a colonoscopy, and such detections will be visible to the doctor during the regular colonoscopy procedure. This medical device is called Endoscopy Video Assistance for Colonoscopy (EVA-C). EVA-C, an investigational device, has been developed to assist the doctor in identifying possible polyps, but is not meant to replace their decision making.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥ years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
- Between the ages of 45 and 80 years, inclusive.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Self-reported pregnancy.
- Known diagnosis of Colorectal Cancer.
- History of, or referral for, Inflammatory Bowel Disease.
- Previous surgery involving the colon or rectum.
- Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
- High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
- Referral for overt, symptomatic gastrointestinal bleeding.
Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Cadman Leggett, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available