EAGLE Trial CADDIE Artificial Intelligence Endoscopy

Last updated: July 1, 2024
Sponsor: Odin Medical
Overall Status: Completed

Phase

N/A

Condition

Rectal Cancer

Colon Polyps

Polyps

Treatment

CADDIE

Clinical Study ID

NCT05730192
RCT-2022-01
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Screening or surveillance colonoscopy

  2. Age 40 years or older

  3. Informed consent

Exclusion

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

Total Participants: 985
Treatment Group(s): 1
Primary Treatment: CADDIE
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
November 29, 2023

Study 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.

Connect with a study center

  • Israeli-Georgian Medical Research Clinic Healthycore

    Tbilisi,
    Georgia

    Site Not Available

  • Sana Klinikum Lichtenberg

    Berlin,
    Germany

    Site Not Available

  • Humanitas Mater Domini

    Castellanza, Varese 21100
    Italy

    Site Not Available

  • Humanitas Catania

    Catania, 95045
    Italy

    Site Not Available

  • Humanitas Research Hospital

    Milan, 20089
    Italy

    Site Not Available

  • H-T. Centrum Medyczne

    Tychy, 43-100
    Poland

    Site Not Available

  • Przychodnia Polskiej Fundacji Gastroenterologii

    Warsaw, 00-631
    Poland

    Site Not Available

  • The Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 00-001
    Poland

    Site Not Available

  • University Hospital "Clinico Lozano Blesa" of Zaragoza

    Zaragoza,
    Spain

    Site Not Available

  • University College Hospital London

    London,
    United Kingdom

    Site Not Available

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