CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

  • End date
    Nov 8, 2023
  • participants needed
  • sponsor
    University College, London
Updated on 10 October 2021
adenomatous polyps
computer assisted diagnosis
aided diagnosis
computer assisted



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.

Condition Colorectal Polyp, Adenoma Colon, Colon Polyps, COLONIC POLYP, Polyps, Colorectal Polyps, Polyp, Colon Adenoma
Treatment CADDIE- Computer Aided (AI) Device used in Endoscopy
Clinical Study IdentifierNCT04325815
SponsorUniversity College, London
Last Modified on10 October 2021


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Inclusion Criteria

Patient's scheduled to undergo a surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial
Male and female participants aged 18 years or older at the time of informed consent
Patient's able to comprehend, sign and date the written informed consent document to participate in the study

Exclusion Criteria

Emergency colonoscopies and/or inpatient colonoscopies
Patients with inflammatory bowel disease (IBD)
Patients with Colorectal Cancer (CRC)
Patients with previous CRC
Patients with previous colonic resection
Patients returning for a planned elective therapeutic colonoscopy
Polyposis syndromes
Current or relevant history of a physical or psychiatric illness or any medical condition that in the opinion of the investigator could affect the patient's safety or interfere with the study assessments
Patients with a contraindication for biopsy or polypectomy. These include
Patients who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines 30
Patients with a history of haemostasis disorders (Haemostasis disorders will include but will not be limited to: patients with haemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders)
Patients is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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