EAGLE Trial CADDIE Artificial Intelligence Endoscopy

Colorectal Cancer Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730192
• Other study ID #: RCT-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Odin Medical
• Contact: Monica Tocchi, MD, PhD
• Phone: +1 646 933 1025
• Email: m.tocchi[@]meditrial.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Polyps
• Colorectal Cancer
• Polyp of Colon

Intervention

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.

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Healthycore	Tbilisi
Germany	Sana Klinikum Lichtenberg	Berlin
Italy	Humanitas Mater Domini	Castellanza	Varese
Italy	Humanitas Catania	Catania
Italy	Humanitas Research Hospital	Milan
Poland	H-T. Centrum Medyczne	Tychy
Poland	Przychodnia Polskiej Fundacji Gastroenterologii	Warsaw
Poland	The Maria Sklodowska-Curie National Research Institute of Oncology	Warsaw
Spain	University Hospital "Clinico Lozano Blesa" of Zaragoza	Zaragoza
United Kingdom	University College Hospital London	London

Sponsors (2)

Lead Sponsor	Collaborator
Odin Medical	Meditrial Europe Ltd.

Countries where clinical trial is conducted

Georgia,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

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

External Links

•   Meditrial Clinical Research Organization
•   Odin Vision Cloud Connected Endoscopy