EAGLE Trial CADDIE Artificial Intelligence Endoscopy

Study Overview
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Brief Summary
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The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.

Detailed Description
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The EAGLE study will be conducted with a parallel design. Patients who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADDIE Arm) using CADDIE or standard colonoscopy without CADe (Control Arm). All resected polyps will be submitted for histologic examination.

Official Title
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Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)

Conditions
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Adenoma Colon, Colorectal Cancer, Polyp of Colon

Intervention / Treatment
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* Device: CADDIE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening or surveillance colonoscopy Age 40 years or older Informed consent Exclusion Criteria: Emergency colonoscopies Inflammatory bowel disease (IBD) Colorectal Cancer (CRC) Previous Colorectal Cancer (CRC) Previous colonic resection Returning for a planned elective therapeutic colonoscopy. Polyposis syndromes (familial adenomatous polyposis) Contraindication for biopsy or polypectomy.

Ages Eligible for Study
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Minimum Age: 40 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel trial design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CADDIE colonoscopy (CADDIE Arm)<br>CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. | Device: CADDIE<br>* A colonoscopy is an examination of the bowels using a colonoscope, or a thin, flexible tube with a light and camera. It can help identify issues like colorectal cancer, polyps, and ulcers.<br>* Other names: Colonoscopy;|
| Active Comparator: Standard high-definition white light colonoscopy (Control Arm)<br>Patients will receive a standard colonoscopy | Device: CADDIE<br>* A colonoscopy is an examination of the bowels using a colonoscope, or a thin, flexible tube with a light and camera. It can help identify issues like colorectal cancer, polyps, and ulcers.<br>* Other names: Colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adenoma per colonoscopy (APC) | Superiority of CADDIE Arm vs. control. | During the procedure/surgery | 
| Positive percent agreement (PPA) | Non inferiority of CADDIE Arm vs. control. | During the procedure/surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Surveillance, Artificial Intelligence, Colonoscopy