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Completed

NCT Number: NCT04325815

CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

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 screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Each 1.0% increase in ADR is associated with a 3.0% decrease in the risk of the patient developing an interval CRC. There remains a wide variation in endoscopist ADR.

More recently, the use of artificial intelligence (AI) and computer aided diagnosis in endoscopy has been gaining increasing attention for its role in automated lesion detection and characterisation. AI can potentially improve ADR, but previous AI related work has largely focused on retrospectively assessing still endoscopic images and selected video sequences which may be subject to bias and lack clinical utility. There are only limited clinical studies evaluating the effect of AI in improving ADR.

The CADDIE device uses convolutional neural networks developed for computer assisted detection and computer assisted diagnosis of polyps.

Primary objective: To determine whether the CADDIE artificial intelligence system improves endoscopic detection of adenomas during colonoscopy.

Primary endpoint: The difference in adenoma detection rate (ADR) between the intervention (supported with the CADDIE system) and non-intervention arm

Study design: Multi-Centre, open-label, randomised, prospective trial to assess efficacy and safety of the CADDIE artificial intelligence system for improving endoscopic detection of colonic polyps in real-time.

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Key information

Conditions

Polyps Adenoma Colon Colon Polyp Colonic Polyps Colorectal Polyp Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

CADDIE- Computer Aided (AI) Device used in Endoscopy

Device
  • CADDIE assisted polyp detection
  • CADDIE assisted polyp characterisation

Primary outcomes

  1. To Evaluate Whether Using the CADDIE System Improves Endoscopist Detection of Adenomas During Colonoscopy.

    Time frame: 30 days

    The difference in endoscopist ADR between the intervention (CADDIE system) and non-intervention arm.

Secondary outcomes

  1. Evaluate the Difference in Number of Adenomas Detected Per Colonoscopy Between Intervention and Non-intervention Arm

    Time frame: 30 days

    Compare the difference in the number of adenomas detected per colonoscopy between the intervention and non-intervention arm

  2. To Determine Whether the CADDIE Artificial Intelligence System Improves Endoscopic Detection of All Polyps During Colonoscopy

    Time frame: 30 days

    Polyp Detection Rate (including proximal polyp detection rate) in the interventional group compared to the control group.

    • Mean number of polyps detected per colonoscopy in the interventional group compared to the control group.

  3. Compare the Accuracy of Endoscopist Optical Diagnosis of Diminutive Polyps When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)

    Time frame: 30 days

    Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive polyps. Accuracy is defined as true positive and true negative divided by diagnoses total polyps that were optically diagnosed with high confidence.

  4. Compare the Accuracy of Endoscopist Optical Diagnosis to Assign Colonoscopy Surveillance Intervals When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)

    Time frame: 30 days

    Compare the accuracy of using CADDIE's optical diagnosis to assign surveillance colonoscopy intervals against using human endoscopist optical diagnosis (high confidence diagnoses) for assigning surveillance colonoscopy intervals.

  5. Compare the Accuracy of Endoscopist Optical Diagnosis of Diminutive Rectal Polyps When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)

    Time frame: 30 days

    Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive rectal polyps.

  6. Evaluate the Safety of the CADDIE by Recording Occurrence and Severity of Adverse Events.

    Time frame: 30 days

    Safety of the device will be assessed through monitoring of adverse events for 30 days' post-procedure. Adverse events are defined as:

    • Abdominal pain/discomfort.
    • Abdominal bloating.
    • Sedation related aspiration.
    • Bleeding risk.
    • Perforation.
    • Post polypectomy electrocoagulation syndrome.
    • Infection.

  7. Assess Patient Anxiety During the Colonoscopy

    Time frame: 30 days

    Patient response to the question 'How anxious or calm were you during the colonoscopy?' assessed by Likert Scale with 5 options - 1 (Very anxious), 2 (Somewhat anxious), 3 (Neither Anxious nor calm), 4 (Somewhat calm), 5 (Very calm).

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

Multi-Centre, Open-label, Randomised, Prospective Trial to Assess Efficacy and Safety of the CADDIE Artificial Intelligence System for Improving Endoscopic Detection of Colonic Polyps in Real-time.

Acronym: CADDIE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2020
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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