CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Polyps, Adenoma Colon, Colorectal Polyp, Colon Polyp

Intervention / Treatment
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* Device: CADDIE- Computer Aided (AI) Device used in Endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CADDIE<br>The endoscopist will be assisted with CADDIE system to detect polyps. The endoscopist will perform optical diagnosis of polyps with the assistance of the CADDIE's polyp characterisation function. | Device: CADDIE- Computer Aided (AI) Device used in Endoscopy<br>* CADDIE assisted polyp detection CADDIE assisted polyp characterisation<br>|
| Standard Procedure<br>In addition to routine colonoscopy the endoscopist will perform optical diagnosis of detected polyps without the assistance of the CADDIE. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether using the CADDIE system improves endoscopist detection of adenomas during colonoscopy. | The difference in endoscopist ADR between the intervention (CADDIE system) and non-intervention arm. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the difference in number of adenomas detected per colonoscopy between intervention and non-intervention arm | Compare the difference in the number of adenomas detected per colonoscopy between the intervention and non-intervention arm | 3 years | 
| To determine whether the CADDIE artificial intelligence system improves endoscopic detection of all polyps during colonoscopy | 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 years | 
| 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) | Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive polyps. | 3 years | 
| 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) | 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. | 3 years | 
| 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) | Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive rectal polyps. | 3 years | 
| Evaluate the safety of the CADDIE by recording occurrence and severity of adverse events. | 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. | 3 years | 
| Assess integration of CADDIE into normal colonoscopy clinical workflow. | - Endoscopist/endoscopy nurse/patient experience and acceptability of the CADDIE system assessed by qualitative questionnaire. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, Endoscopy, ADR