EAGLE Trial CADDIE Artificial Intelligence Endoscopy (EAGLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Polyp of Colon; Adenoma Colon
• Intervention / Treatment: Device: CADDIE

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.

• Study Type: Interventional
• Enrollment (Estimated): 950
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Tocchi, MD, PhD; Phone Number: +1 646 933 1025; Email: m.tocchi@meditrial.net

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Israeli-Georgian Medical Research Clinic HEALTHYCORE
    • Contact: Nana Kiknadze, Dr.
• Germany
  • Berlin, Germany
    • Recruiting
    • Sana Klinikum Lichtenberg
    • Contact: Siegbert Faiss, Prof, Dr.
• Italy
  • Catania, Italy, 95045
    • Recruiting
    • Humanitas Catania
    • Contact: Giacomo Bonanno, Dr.
  • Milan, Italy, 20089
    • Recruiting
    • Humanitas Research Hospital
    • Contact: Alessandro Repici, Prof.
    • Sub-Investigator: Cesare Hassan, Prof.
  • Varese
    • Castellanza, Varese, Italy, 21100
      • Recruiting
      • Humanitas Mater Domini
      • Contact: Benedetto Mangiavillano, Prof.
• Poland
  • Tychy, Poland, 43-100
    • Recruiting
    • H-T. Centrum Medyczne
    • Contact: Tomasz Romańczyk, Dr n. med.
  • Warsaw, Poland, 00-001
    • Recruiting
    • The Maria Sklodowska-Curie National Research Institute of Oncology
    • Contact: Michał Kamiński, Prof.
  • Warsaw, Poland, 00-631
    • Recruiting
    • Przychodnia Polskiej Fundacji Gastroenterologii
    • Contact: Bronisław Kotowski, Dr.
• Spain
  • Zaragoza, Spain
    • Recruiting
    • University Hospital "Clinico Lozano Blesa" of Zaragoza
    • Contact: Angel Lanas, Prof, Dr.
• United Kingdom
  • London, United Kingdom
    • Withdrawn
    • University College Hospital London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Colonoscopy
Active Comparator: Standard high-definition white light colonoscopy (Control Arm); Patients will receive a standard colonoscopy	Device: 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.; Other Names: Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adenoma per colonoscopy (APC)	Superiority of CADDIE Arm vs. control.	During the procedure/surgery
Positive percent agreement (PPA)	Non inferiority of CADDIE Arm vs. control.	During the procedure/surgery

Collaborators and Investigators

• Sponsor: Odin Medical
• Collaborators: Meditrial Europe Ltd.
• Investigators: Principal Investigator: Alessandro Repici, Prof., Humanitas Research Hospital

Publications and helpful links

Helpful Links

• Meditrial Clinical Research Organization
• Odin Vision Cloud Connected Endoscopy

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Colonoscopy; Artificial Intelligence; Surveillance
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: RCT-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No