Status:

COMPLETED

CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

Lead Sponsor:

University College, London

Conditions:

Polyps

Adenoma Colon

Eligibility:

All Genders

18+ years

Brief Summary

Background: Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for ...

Eligibility Criteria

Inclusion

  • Patient's scheduled to undergo a 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.
  • Patient's able to comprehend, sign and date the written informed consent document to participate in the study.

Exclusion

  • Emergency colonoscopies and/or inpatient colonoscopies.
  • Patients with inflammatory bowel disease (IBD)
  • Patients with Colorectal Cancer (CRC)
  • Patients with previous CRC
  • Patients with previous colonic resection
  • Patients returning for a planned elective therapeutic colonoscopy.
  • Polyposis syndromes
  • Current or relevant history of a physical or psychiatric illness or any medical condition that in the opinion of the investigator could affect the patient's safety or interfere with the study assessments
  • Patients with a contraindication for biopsy or polypectomy. These include:
  • Patients who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines 30.
  • Patients with a history of haemostasis disorders (Haemostasis disorders will include but will not be limited to: patients with haemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders).
  • Patients is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding

Key Trial Info

Start Date :

April 29 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 8 2023

Estimated Enrollment :

739 Patients enrolled

Trial Details

Trial ID

NCT04325815

Start Date

April 29 2021

End Date

March 8 2023

Last Update

February 19 2025

Active Locations (1)

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1

University College London

London, United Kingdom