EAGLE Trial
Research type
Research Study
Full title
Evaluation of AI for detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
IRAS ID
319223
Contact name
Manish Chand
Contact email
Sponsor organisation
ODIN MEDICAL Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Abnormal growths in the colon and rectum are referred to as polyps. Polyps can be harmless (such as hyperplastic polyps in the rectum) or harmful (for example adenomatous polyps or sessile serrated lesions (SSLs)). Colonoscopy is considered the ‘gold standard’ for detecting polyps and cancer in the large intestine. Yet a major challenge in colonoscopy is the significant miss rates for these polyps.
Using ‘artificial intelligence’ (AI), Odin Vision has developed a device called CADDIE which can help the endoscopist to detect polyps, with an aim to reduce the amount of “missed” polyps.
EAGLE is a multicentre study to evaluate the clinical performance and safety of CADDIE in patients referred for screening or surveillance colonoscopy. CADDIE comprises a computer attached to the output of the endoscopy stack and a screen which shows normal colon video output in real-time. CADDIE processes information contained in digital images in real-time during endoscopy procedures. It informs the endoscopist where there might be a polyp by highlighting areas of interest on the screen with a bounding box and an optional sound alarm. CADDIE does not involve any personal contact with the patient. All decisions are still made by the endoscopist.
The target population are patients undergoing a screening or surveillance colonoscopy. Consenting patients will be registered and randomised to intervention (=routine colonoscopy with CADDIE), or control group (=routine colonoscopy without CADDIE).
To answer the main research question, we will evaluate whether more polyps, particularly precancerous adenomatous polyps, are identified when using CADDIE compared to without as well as whether using CADDIE leads the endoscopist to incorrectly identifying polyps.
We will recruit 946 patients to allow for an expected dropout rate of 10% leaving 860 patients in the study. There are no study-related follow up visits.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0106
Date of REC Opinion
3 Mar 2023
REC opinion
Further Information Favourable Opinion