Early DiAgnosis Real-Time Healthcare System for CANcer Trial

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

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

Conditions6

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