Early DiAgnosis Real-Time Healthcare System for CANcer Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Emergency and/or inpatient colonoscopies
Participants with inflammatory bowel disease (IBD)
Participants with current Colorectal Cancer (CRC)
Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines.
Trial design
Treatments tested in this trial
- CADDIE - Computer Aided Detection and Diagnosis for Intelligent Endoscopy
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov