EndoBRAIN International Version 11
Research type
Research Study
Full title
Real-Time Artificial Intelligence Aided Diagnosis of Colorectal Polyps during Colonoscopy: A Multicenter Clinical Trial with the EndoBRAIN Technology
IRAS ID
260047
Contact name
Amyn Haji
Contact email
Sponsor organisation
R&I Manager
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UMIN Clinical Trials Registry, UMIN000035213
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Removing precancerous polyps from the bowel during a colonoscopy (camera test) is the cornerstone of colorectal cancer screening and prevents polyps developing into bowel cancer. Most polyps develop in the rectosigmoid colon (lower part of the bowel). Many polyps never grow into cancer and it can be difficult for the clinicians performing the procedure (endoscopists) to tell which ones are precancerous. This means many polyps are removed unnecessarily, with a considerable waste of resources.
A recent preliminary study indicates a novel artificial intelligence system (EndoBRAIN) for computer-aided diagnosis may be able to distinguish different types of polyps during colonoscopy and therefore help doctors decide which polyps to remove. This study aims to compare the in accuracy of artificial intelligence against the endoscopist’s assessment for diagnosis of diminutive (<5mm) polyps in the lower colon.
Patients who are age 18 years or older who undergo colonoscopy for any indication at the participating clinical centres and are diagnosed with diminutive rectosigmoid polyps are eligible for study enrolment. For each detected polyp in the rectosigmoid colon, endoscopists will assess the polyp type using standard colonoscopies (cameras) and then with the use of the EndoBRAIN technology.
The polyps will be removed and sent to the laboratory for testing. The difference between clinician diagnosis and EndoBRAIN diagnosis will be compared with the laboratory findings. We hypothesize that the EndoBRAIN technology provides a superior accuracy in identifying precancerous rectosigmoid polyps, compared to endoscopist’s own prediction with a standard colonoscope.
If the trial confirms the superior accuracy of the EndoBRAIN system, polyps classified as non-cancerous with the EndoBRAIN system no longer need to be removed, meaning a large gain for patients and society, due to significantly less polypectomies and pathology reviews.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0610
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion