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Completed

NCT Number: NCT05730192

EAGLE Trial CADDIE Artificial Intelligence Endoscopy

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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Key information

Conditions

Colorectal Cancer Adenoma Colon Colonic Diseases Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp of Colon Polyps Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Israeli-Georgian Medical Research Clinic Healthycore, Tbilisi, Georgia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CADDIE

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.

Other names: Colonoscopy

Primary outcomes

  1. Number of Adenoma per colonoscopy (APC)

    Time frame: During the procedure/surgery

    Superiority of CADDIE Arm vs. control.

  2. Positive percent agreement (PPA)

    Time frame: During the procedure/surgery

    Non inferiority of CADDIE Arm vs. control.

Sponsors and collaborators

Lead sponsor

Odin Medical

Industry

Collaborators

  • Meditrial Europe Ltd.

Registry information

Official study title

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

Acronym: EAGLE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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