EAGLE Trial CADDIE Endoscopy

Sponsor

Odin Medical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05730192

Collaborator

Meditrial Europe Ltd. (Industry)

950

Enrollment

Locations

Arms

18.1

Anticipated Duration (Months)

237.5

Patients Per Site

13.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Polyp of Colon Adenoma Colon	Device: CADDIE	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

950 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel trial designParallel trial design

Masking:

Single (Outcomes Assessor)

Masking Description:

Histology of the polyps is performed by the pathologist blinded to the study group assignment.

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adenoma per colonoscopy (APC) [During the procedure/surgery]
Superiority of CADDIE Arm vs. control.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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)
Colorectal Cancer (CRC)
previous colonic resection
Returning for a planned elective therapeutic colonoscopy.
Polyposis syndromes (familial adenomatous polyposis)
Contraindication for biopsy or polypectomy.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Sana Klinikum Lichtenberg	Berlin	Germany
2	Humanitas Research Hospital	Milan	Italy	20089
3	University Hospital "Clinico Lozano Blesa" of Zaragoza	Zaragoza	Spain
4	University College Hospital London	London	United Kingdom