AI-assisted colonoscopy for diagnosing colorectal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.