- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325815
CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy (CADDIE)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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London, United Kingdom
- University College London
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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CADDIE
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.
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Standard Procedure
In addition to routine colonoscopy the endoscopist will perform optical diagnosis of detected polyps without the assistance of the CADDIE.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate whether using the CADDIE system improves endoscopist detection of adenomas during colonoscopy.
Time Frame: 3 years
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The difference in endoscopist ADR between the intervention (CADDIE system) and non-intervention arm.
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3 years
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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
Time Frame: 3 years
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Compare the difference in the number of adenomas detected per colonoscopy between the intervention and non-intervention arm
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3 years
|
To determine whether the CADDIE artificial intelligence system improves endoscopic detection of all polyps during colonoscopy
Time Frame: 3 years
|
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)
Time Frame: 3 years
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Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive polyps.
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3 years
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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: 3 years
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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.
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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)
Time Frame: 3 years
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Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive rectal polyps.
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3 years
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Evaluate the safety of the CADDIE by recording occurrence and severity of adverse events.
Time Frame: 3 years
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Safety of the device will be assessed through monitoring of adverse events for 30 days' post-procedure. Adverse events are defined as:
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3 years
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Assess integration of CADDIE into normal colonoscopy clinical workflow.
Time Frame: 3 years
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- Endoscopist/endoscopy nurse/patient experience and acceptability of the CADDIE system assessed by qualitative questionnaire.
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manish Chand, MBBS FRCS PhD, UCL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 126166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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