RecruitingNCT05064124

Early DiAgnosis Real-Time Healthcare System for CANcer Trial

Sponsor

University College, London

Enrollment

420 participants

Start Date

Jul 18, 2024

Study Type

OBSERVATIONAL

Conditions

Colorectal Polyp Polyps Adenoma Colon Colon Polyp Polyps of Colon

Summary

The purpose of the study is to assess whether the AI characterisation system of the CADDIE device improves the endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps in the bowel during colonoscopy. Participants will either have a colonoscopy with the assistance of the CADDIE device characterisation AI system ("intervention group") or have a colonoscopy in line with routine clinical practice i.e., without the CADDIE device characterisation AI system ("control group"). The randomisation method of this trial will allocate enrolled participants to the "intervention" group and to the "control" group by a technique similar to flipping a coin.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (DARWIN) tests a real-time AI-assisted system that helps doctors spot polyps and potential cancer during a colonoscopy. The goal is to improve early cancer detection rates during routine bowel cancer screening or surveillance procedures. **You may be eligible if...** - You are 18 or older and scheduled for a colonoscopy (screening, surveillance, or for symptoms) at a participating hospital - You are able to provide informed consent **You may NOT be eligible if...** - Your colonoscopy is an emergency or you are an inpatient - You have inflammatory bowel disease (IBD) - You currently have colorectal cancer - You have a bleeding disorder, are on blood thinners you haven't stopped before the procedure, or have very low platelet counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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