CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

NCT ID: NCT04325815

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 739 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2023-03-08

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.

Conditions

Polyps; Adenoma Colon; Colorectal Polyp; Colon Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CADDIE

The endoscopist will be assisted with CADDIE system to detect polyps. The endoscopist will perform optical diagnosis of polyps with the assistance of the CADDIE's polyp characterisation function.

CADDIE- Computer Aided (AI) Device used in Endoscopy

Intervention Type: DEVICE

1. CADDIE assisted polyp detection

2. CADDIE assisted polyp characterisation

Standard Procedure

In addition to routine colonoscopy the endoscopist will perform optical diagnosis of detected polyps without the assistance of the CADDIE.

No interventions assigned to this group

Interventions

CADDIE- Computer Aided (AI) Device used in Endoscopy

1. CADDIE assisted polyp detection

2. CADDIE assisted polyp characterisation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manish Chand, MBBS FRCS PhD

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

University College London

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

126166

Identifier Type: -

Identifier Source: org_study_id