AI-assisted colonoscopy for diagnosing colorectal polyps
Early DiAgnosis Real-Time Healthcare System for CANcer Trial
This study is testing whether using an AI device during colonoscopy can help doctors find small colorectal polyps more accurately compared to a regular colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05064124 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the CADDIE device, which utilizes artificial intelligence to enhance the optical diagnosis of diminutive colorectal polyps during colonoscopy. Participants will be randomly assigned to either receive a colonoscopy with the AI system's assistance or undergo a standard procedure without it. The study aims to improve endoscopist accuracy in diagnosing polyps by providing real-time AI-generated overlays on the endoscopy screen. The endoscopists involved will have their expertise assessed to ensure consistency in the procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for a screening, surveillance, or symptomatic colonoscopy.
Not a fit: Patients with inflammatory bowel disease, current colorectal cancer, or those requiring emergency colonoscopies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of colorectal polyps, potentially reducing the risk of colorectal cancer.
How similar studies have performed: Other studies utilizing AI in endoscopy have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants scheduled to undergo a screening, 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. * Participants able to comprehend, sign and date the written informed consent document to participate in the study. Exclusion Criteria: * Emergency and/or inpatient colonoscopies * Participants with inflammatory bowel disease (IBD) * Participants with current Colorectal Cancer (CRC) * Participants with a contraindication for biopsy or polypectomy. These include: * Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines. * Participants with a history of haemostasis disorders (haemostasis disorders will include but will not be limited to: participants with haemophilia or other congenitally acquired clotting factor deficiencies, participants with cirrhosis with coagulopathy, participants known to have thrombocytopenia (\<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders) * Participant is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding
Where this trial is running
London
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Manish Chand, MBBS FRCS PhD — Ucl
- Study coordinator: Sharon Cheung, MSc
- Email: sharon.cheung@ucl.ac.uk
- Phone: 02076795217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.