Actively Recruiting
Early DiAgnosis Real-Time Healthcare System for CANcer Trial evaluating CADDIE AI device in colonoscopy for colorectal polyps
Led by University College, London · Updated on 2024-12-16
420
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the CADDIE device, which uses artificial intelligence (AI) to assist in identifying and characterizing small colorectal polyps during colonoscopy, improves the accuracy of endoscopists. The study compares colonoscopies performed with the CADDIE AI system against those done with routine practice without AI assistance. This observational study uses random allocation to place participants into either the AI-assisted or control group to assess the device's impact on optical diagnosis accuracy of polyps 5mm or smaller. The CADDIE system consists of a computer connected to the endoscopy equipment and displays real-time video with AI-generated overlays highlighting polyp features. Endoscopists can activate the AI characterisation by pressing a foot pedal during the procedure. Both groups have colonoscopies recorded, but AI assistance is only active for the intervention group. Polyps under 10mm are measured, imaged in different lighting modes, optically diagnosed, and resected or biopsied if hyperplastic and located in the rectosigmoid area. Each polyp is labeled and sent for histopathology, which serves as the reference standard. Participants undergo colonoscopy with data entered into an electronic system to randomize group assignment. Endoscopists document polyp details, complete diagnosis forms, and record procedure timing and quality markers. The study also evaluates the device's safety through adverse event monitoring and assesses acceptability via questionnaires for staff and participants. The primary outcome is the accuracy of optical polyp diagnosis over one year, with secondary measures including diagnostic confidence, surveillance interval concordance, and device integration into clinical workflow.
CONDITIONS
Brief Title
Early DiAgnosis Real-Time Healthcare System for CANcer Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants scheduled for screening, surveillance, or symptomatic colonoscopy with a participating endoscopist
- Male or female participants aged 18 years or older at consent
- Participants able to understand and sign informed consent
You will not qualify if you...
- Emergency or inpatient colonoscopies
- Participants with inflammatory bowel disease (IBD)
- Participants with current colorectal cancer
- Participants with contraindications to biopsy or polypectomy, including not withholding bleeding-risk medications per guidelines
- Participants with bleeding disorders such as haemophilia, cirrhosis with coagulopathy, thrombocytopenia (platelets <80,000/µl), Von Willebrand's disease, or platelet malfunction
- Participants enrolled in other research studies with investigational products that increase bleeding risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo a colonoscopy procedure either with the CADDIE device assisted AI system or standard practice without the AI system. During the colonoscopy, polyps are detected, measured, optically diagnosed, and resected or biopsied as per protocol. Data including polyp images, optical diagnoses, and histopathology samples are collected.
1 visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety and acceptability of the CADDIE device through adverse event tracking and questionnaires administered to participants, endoscopists, and nurses. Endoscopy performance markers such as procedural times are also observed.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
S
Sharon Cheung, MSc
R
Rawen Kader, MBBS MRCP
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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