Clinical trial NCT04325815: CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyps
Adenoma Colon
Colorectal Polyp
Colon Polyp
Keywords: Artificial Intelligence
Endoscopy
ADR
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include patient's scheduled to undergo a surveillance or symptomatic colonoscopy at the participating sites.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: To Evaluate Whether Using the CADDIE System Improves Endoscopist Detection of Adenomas During Colonoscopy.
timeFrame: 30 days
Secondary outcomes:
measure: Evaluate the Difference in Number of Adenomas Detected Per Colonoscopy Between Intervention and Non-intervention Arm
timeFrame: 30 days
measure: To Determine Whether the CADDIE Artificial Intelligence System Improves Endoscopic Detection of All Polyps During Colonoscopy
timeFrame: 30 days
measure: 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)
timeFrame: 30 days
measure: 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)
timeFrame: 30 days
measure: 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)
timeFrame: 30 days
measure: Evaluate the Safety of the CADDIE by Recording Occurrence and Severity of Adverse Events.
timeFrame: 30 days
measure: Assess Patient Anxiety During the Colonoscopy
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: UCL
name: Manish Chand, MBBS FRCS PhD
role: PRINCIPAL_INVESTIGATOR
References: