MedTrace Logo

CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

NCT04325815 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 739

Last updated 2025-02-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Polyps
  • Adenoma Colon
  • Colorectal Polyp
  • Colon Polyp

Interventions

DEVICE

CADDIE- Computer Aided (AI) Device used in Endoscopy

1. CADDIE assisted polyp detection 2. CADDIE assisted polyp characterisation

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Manish Chand, MBBS FRCS PhD · UCL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2023-03-08
Completion
2023-03-08

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325815 on ClinicalTrials.gov