CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

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.

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.

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