EAGLE Trial CADDIE Artificial Intelligence Endoscopy

Not Applicable

Completed

• Conditions: Polyp of Colon; Adenoma Colon; Colorectal Cancer
• Interventions: Device: CADDIE

• Registration Number: NCT05730192
• Lead Sponsor: Odin Medical

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-15
• Study Start: 2023-05-10
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 985

Inclusion Criteria

1. Screening or surveillance colonoscopy
2. Age 40 years or older
3. Informed consent

Exclusion Criteria

1. Emergency colonoscopies
2. Inflammatory bowel disease (IBD)
3. Colorectal Cancer (CRC)
4. Previous Colorectal Cancer (CRC)
5. Previous colonic resection
6. Returning for a planned elective therapeutic colonoscopy.
7. Polyposis syndromes (familial adenomatous polyposis)
8. Contraindication for biopsy or polypectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard high-definition white light colonoscopy (Control Arm)	CADDIE	Patients will receive a standard colonoscopy
CADDIE colonoscopy (CADDIE Arm)	CADDIE	CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.

Primary Outcome Measures

Name	Time	Method
Number of Adenoma per colonoscopy (APC)	During the procedure/surgery	Superiority of CADDIE Arm vs. control.
Positive percent agreement (PPA)	During the procedure/surgery	Non inferiority of CADDIE Arm vs. control.

Trial Locations

Locations (9)

Israeli-Georgian Medical Research Clinic Healthycore; 🇬🇪 Tbilisi, Georgia

Sana Klinikum Lichtenberg; 🇩🇪 Berlin, Germany

Humanitas Mater Domini; 🇮🇹 Castellanza, Varese, Italy

The Maria Sklodowska-Curie National Research Institute of Oncology; 🇵🇱 Warsaw, Poland

H-T. Centrum Medyczne; 🇵🇱 Tychy, Poland

Przychodnia Polskiej Fundacji Gastroenterologii; 🇵🇱 Warsaw, Poland

Humanitas Catania; 🇮🇹 Catania, Italy

Humanitas Research Hospital; 🇮🇹 Milan, Italy

University Hospital "Clinico Lozano Blesa" of Zaragoza; 🇪🇸 Zaragoza, Spain