NCT05730192

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
985

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

January 23, 2023

Last Update Submit

July 1, 2024

Conditions

Colorectal CancerPolyp of ColonAdenoma Colon

Keywords

ScreeningSurveillanceArtificial IntelligenceColonoscopy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

CADDIE colonoscopy (CADDIE Arm)

EXPERIMENTAL

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

Standard high-definition white light colonoscopy (Control Arm)

ACTIVE COMPARATOR

Patients will receive a standard colonoscopy

Device: CADDIE

Interventions

CADDIEDEVICE

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.

Also known as: Colonoscopy
CADDIE colonoscopy (CADDIE Arm)Standard high-definition white light colonoscopy (Control Arm)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening or surveillance colonoscopy
  • Age 40 years or older
  • Informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

Location

Sana Klinikum Lichtenberg

Berlin, Germany

Location

Humanitas Mater Domini

Castellanza, Varese, 21100, Italy

Location

Humanitas Catania

Catania, 95045, Italy

Location

Humanitas Research Hospital

Milan, 20089, Italy

Location

H-T. Centrum Medyczne

Tychy, 43-100, Poland

Location

The Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, 00-001, Poland

Location

Przychodnia Polskiej Fundacji Gastroenterologii

Warsaw, 00-631, Poland

Location

University Hospital "Clinico Lozano Blesa" of Zaragoza

Zaragoza, Spain

Location

Related Publications (1)

  • Kader R, Hassan C, Lanas A, Romanczyk M, Romanczyk T, Kotowski B, Homedes CS, Mangiavillano B, Bonanno G, Lovat LB, Kaminski M, Faiss S, Repici A. A novel cloud-based artificial intelligence for real-time detection of colorectal neoplasia - a randomized controlled trial (EAGLE). NPJ Digit Med. 2025 Dec 26;9(1):84. doi: 10.1038/s41746-025-02270-1.

    PMID: 41449203DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Alessandro Repici, Prof.

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Histology of the polyps is performed by the pathologist blinded to the study group assignment.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Parallel trial design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 15, 2023

Study Start

May 10, 2023

Primary Completion

November 20, 2023

Study Completion

November 29, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(3)GE(1)IT(3)ES(1)DE(1)