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Spots Global Cancer Trial Database for CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

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Trial Identification

Brief Title: CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

Official Title: Multi-Centre, Open-label, Randomised, Prospective Trial to Assess Efficacy and Safety of the CADDIE Artificial Intelligence System for Improving Endoscopic Detection of Colonic Polyps in Real-time.

Study ID: NCT04325815

Study Description

Brief Summary: Background: Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Each 1.0% increase in ADR is associated with a 3.0% decrease in the risk of the patient developing an interval CRC. There remains a wide variation in endoscopist ADR. More recently, the use of artificial intelligence (AI) and computer aided diagnosis in endoscopy has been gaining increasing attention for its role in automated lesion detection and characterisation. AI can potentially improve ADR, but previous AI related work has largely focused on retrospectively assessing still endoscopic images and selected video sequences which may be subject to bias and lack clinical utility. There are only limited clinical studies evaluating the effect of AI in improving ADR. The CADDIE device uses convolutional neural networks developed for computer assisted detection and computer assisted diagnosis of polyps. Primary objective: To determine whether the CADDIE artificial intelligence system improves endoscopic detection of adenomas during colonoscopy. Primary endpoint: The difference in adenoma detection rate (ADR) between the intervention (supported with the CADDIE system) and non-intervention arm Study design: Multi-Centre, open-label, randomised, prospective trial to assess efficacy and safety of the CADDIE artificial intelligence system for improving endoscopic detection of colonic polyps in real-time.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University College London, London, , United Kingdom

Contact Details

Name: Manish Chand, MBBS FRCS PhD

Affiliation: UCL

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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