EAGLE Trial CADDIE Artificial Intelligence Endoscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05730192

Acronym

EAGLE

Enrollment

985

Registered

2023-02-15

Start date

2023-05-10

Completion date

2023-11-29

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon, Colorectal Cancer, Polyp of Colon

Keywords

Screening, Surveillance, Artificial Intelligence, Colonoscopy

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.

Interventions

DEVICECADDIE

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Masking description

Histology of the polyps is performed by the pathologist blinded to the study group assignment.

Intervention model description

Parallel trial design

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Georgia, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026