EAGLE Trial CADDIE Artificial Intelligence Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

985 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2023-11-29

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.

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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.

Conditions

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Colorectal Cancer Polyp of Colon Adenoma Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel trial design

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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CADDIE colonoscopy (CADDIE Arm)

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

Group Type EXPERIMENTAL

CADDIE

Intervention Type DEVICE

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.

Standard high-definition white light colonoscopy (Control Arm)

Patients will receive a standard colonoscopy

Group Type ACTIVE_COMPARATOR

CADDIE

Intervention Type DEVICE

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.

Interventions

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CADDIE

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.

Intervention Type DEVICE

Other Intervention Names

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Colonoscopy

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No