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EAGLE Trial CADDIE Artificial Intelligence Endoscopy (EAGLE)

Primary Purpose

Colorectal Cancer, Polyp of Colon, Adenoma Colon

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CADDIE
Sponsored by
Odin Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Screening, Surveillance, Artificial Intelligence, Colonoscopy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Israeli-Georgian Medical Research Clinic HealthycoreRecruiting
  • Sana Klinikum LichtenbergRecruiting
  • Humanitas Mater DominiRecruiting
  • Humanitas CataniaRecruiting
  • Humanitas Research HospitalRecruiting
  • H-T. Centrum MedyczneRecruiting
  • The Maria Sklodowska-Curie National Research Institute of OncologyRecruiting
  • Przychodnia Polskiej Fundacji GastroenterologiiRecruiting
  • University Hospital "Clinico Lozano Blesa" of ZaragozaRecruiting
  • University College Hospital London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CADDIE colonoscopy (CADDIE Arm)

Standard high-definition white light colonoscopy (Control Arm)

Arm Description

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

Patients will receive a standard colonoscopy

Outcomes

Primary Outcome Measures

Number of Adenoma per colonoscopy (APC)
Superiority of CADDIE Arm vs. control.
Positive percent agreement (PPA)
Non inferiority of CADDIE Arm vs. control.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2023
Last Updated
September 25, 2023
Sponsor
Odin Medical
Collaborators
Meditrial Europe Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05730192
Brief Title
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Acronym
EAGLE
Official Title
Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Odin Medical
Collaborators
Meditrial Europe Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Polyp of Colon, Adenoma Colon
Keywords
Screening, Surveillance, Artificial Intelligence, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel trial design
Masking
Outcomes Assessor
Masking Description
Histology of the polyps is performed by the pathologist blinded to the study group assignment.
Allocation
Randomized
Enrollment
950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CADDIE colonoscopy (CADDIE Arm)
Arm Type
Experimental
Arm Description
CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.
Arm Title
Standard high-definition white light colonoscopy (Control Arm)
Arm Type
Active Comparator
Arm Description
Patients will receive a standard colonoscopy
Intervention Type
Device
Intervention Name(s)
CADDIE
Other Intervention Name(s)
Colonoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Adenoma per colonoscopy (APC)
Description
Superiority of CADDIE Arm vs. control.
Time Frame
During the procedure/surgery
Title
Positive percent agreement (PPA)
Description
Non inferiority of CADDIE Arm vs. control.
Time Frame
During the procedure/surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Tocchi, MD, PhD
Phone
+1 646 933 1025
Email
m.tocchi@meditrial.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, Prof.
Organizational Affiliation
Humanitas Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Healthycore
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nana Kiknadze, Dr.
Facility Name
Sana Klinikum Lichtenberg
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siegbert Faiss, Prof, Dr.
Facility Name
Humanitas Mater Domini
City
Castellanza
State/Province
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedetto Mangiavillano, Prof.
Facility Name
Humanitas Catania
City
Catania
ZIP/Postal Code
95045
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Bonanno, Dr.
Facility Name
Humanitas Research Hospital
City
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, Prof.
First Name & Middle Initial & Last Name & Degree
Cesare Hassan, Prof.
Facility Name
H-T. Centrum Medyczne
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Romańczyk, Dr n. med.
Facility Name
The Maria Sklodowska-Curie National Research Institute of Oncology
City
Warsaw
ZIP/Postal Code
00-001
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał Kamiński, Prof.
Facility Name
Przychodnia Polskiej Fundacji Gastroenterologii
City
Warsaw
ZIP/Postal Code
00-631
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bronisław Kotowski, Dr.
Facility Name
University Hospital "Clinico Lozano Blesa" of Zaragoza
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Lanas, Prof, Dr.
Facility Name
University College Hospital London
City
London
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.meditrial.net/
Description
Meditrial Clinical Research Organization
URL
https://odin-vision.com/
Description
Odin Vision Cloud Connected Endoscopy

Learn more about this trial

EAGLE Trial CADDIE Artificial Intelligence Endoscopy

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