EAGLE Trial CADDIE Artificial Intelligence Endoscopy

Odin Medical

Status: Completed

Conditions: Polyp of Colon; Adenoma Colon; Colorectal Cancer

Treatments: Device: CADDIE

Study type: Interventional

Funder types: Industry

Identifiers

NCT05730192

RCT-2022-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 985 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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985 participants in 2 patient groups

CADDIE colonoscopy (CADDIE Arm)

Experimental group

Description:

CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.

Treatment:

Device: CADDIE

Standard high-definition white light colonoscopy (Control Arm)

Active Comparator group

Description:

Patients will receive a standard colonoscopy

Treatment:

Device: CADDIE