Colorectal CancerEAGLENCT05730192
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
A study testing Colonoscopy with CADDIE and Standard Colonoscopy in people with Colorectal Cancer and Polyp of Colon, run by Odin Medical at 8 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Cancer, Polyp of Colon, Adenoma Colon
- What is being tested?
- Colonoscopy with CADDIE and Standard Colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 985 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 10 May 2023to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening or surveillance colonoscopy
- Age 40 years or older
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Italy3 sites
Humanitas Mater Domini
Castellanza, Varese, 21100
Humanitas Catania
Catania, 95045
Humanitas Research Hospital
Milan, 20089
Poland3 sites
H-T. Centrum Medyczne
Tychy, 43-100
The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 00-001
Przychodnia Polskiej Fundacji Gastroenterologii
Warsaw, 00-631
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Polyp of Colon, Adenoma Colon
- Being tested
- Colonoscopy with CADDIE, Standard Colonoscopy
- Keywords
- Screening, Surveillance, Artificial Intelligence, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with CADDIEDevice
Also called Colonoscopy
A standard colonoscopy is performed with real-time support of the computer-aided detection (CADe) device CADDIE, used to assist the endoscopist in the detection of colorectal lesions.
Standard ColonoscopyProcedure or surgery
A standard colonoscopy performed without the assistance of any computer-aided detection (CADe) system. Lesion detection relied solely on the endoscopist's visual assessment and clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Colonoscopy with CADDIE |
| Standard high-definition white light colonoscopy (Control Arm) | Active comparator | Patients will receive a standard colonoscopy Receives: Procedure: Standard Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Per Colonoscopy (APC)
The total number of histologically confirmed adenomas and adenocarcinomas divided by the total number of procedures performed.
Measured: During the procedure
Positive Percent Agreement (PPA)
The percent of histologically confirmed adenomas, sessile serrated adenomas and large (>10mm) hyperplastic polyps of the proximal colon (cecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.
Measured: During the procedure
Secondary outcomes (8)
Adenoma Detection Rate (ADR)
The percentage of examinations with at least one histologically confirmed adenoma or adenocarcinoma divided by total number of procedures performed.
Measured: During procedure
Sessile Serrated Adenomas Per Colonoscopy (SSAPC)
Total number of histologically confirmed sessile serrated adenomas, traditional serrated adenomas, or serrated lesion with cytological dysplasia, excluding hyperplastic polyps, divided by the total number of procedures performed.
Measured: During procedure
Sessile Serrated Adenomas Per Colonoscopy* (SSAPC*)
Total number of histologically confirmed sessile serrated adenomas, with or without cytological dysplasia, divided by the total number of procedures performed.
Measured: During procedure
Neoplastic Polyps Per Colonoscopy (NPPC)
Total number of histologically confirmed adenomas, adenocarcinomas, sessile serrated adenomas, and traditional serrated adenomas divided by the total number of procedures performed.
Measured: During procedure
Large Polyps Per Colonoscopy (PPC)
The total number of histologically confirmed polyps ≥ 10 mm detected (adenomas, adenocarcinomas, sessile serrated adenoma, traditional serrated adenoma, hyperplastic), divided by the total number of colonoscopies.
Measured: During procedure
Large Adenoma Per Colonoscopy
The total number of histologically confirmed ≥ 10 mm adenomas and adenocarcinomas divided by the total number of colonoscopies.
Measured: During the procedure
Colonoscope Withdrawal Time of Negative Procedures
The time it takes to withdraw the colonoscope from the furthest point (TI or caecum) for colonoscopies that did not require any biopsies or resections.
Measured: During procedure
Colonoscope Withdrawal Time
The time it takes to withdraw the colonoscope from the furthest point (TI or cecum) back to the rectum, including biopsy
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start10 May 2023
- Primary completion20 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel trial design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, Prof., Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730192
- Sponsor's protocol ID
- RCT-2022-01
- Acronym
- EAGLE
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2023
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41449203
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
- ClinicalTrials.gov ID
- NCT05730192
- Acronym / sponsor ID
- EAGLE / RCT-2022-01
- Conditions
- Colorectal Cancer, Polyp of Colon, Adenoma Colon
- Keywords
- Screening, Surveillance, Artificial Intelligence, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 985 participants (actual)
- Lead sponsor
- Odin MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 10 May 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Posted 26 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel trial design
| Arm | Type | Receives |
|---|---|---|
| CADDIE colonoscopy (CADDIE Arm) | Experimental | Device: Colonoscopy with CADDIECADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. |
| Standard high-definition white light colonoscopy (Control Arm) | Active comparator | Procedure: Standard ColonoscopyPatients will receive a standard colonoscopy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Screening or surveillance colonoscopy
- Age 40 years or older
- Informed consent
Key exclusion criteria (8 listed)
- Emergency colonoscopies
- Inflammatory bowel disease (IBD)
- Colorectal Cancer (CRC)
- Previous Colorectal Cancer (CRC)
- Previous colonic resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy with CADDIEAlso: ColonoscopyA standard colonoscopy is performed with real-time support of the computer-aided detection (CADe) device CADDIE, used to assist the endoscopist in the detection of colorectal lesions. | Device | CADDIE colonoscopy (CADDIE Arm) |
| Standard ColonoscopyA standard colonoscopy performed without the assistance of any computer-aided detection (CADe) system. Lesion detection relied solely on the endoscopist's visual assessment and clinical judgment. | Procedure or surgery | Standard high-definition white light colonoscopy (Control Arm) |
Primary outcome
Adenoma Per Colonoscopy (APC)
Time frame: During the procedure
The total number of histologically confirmed adenomas and adenocarcinomas divided by the total number of procedures performed.
Positive Percent Agreement (PPA)
Time frame: During the procedure
The percent of histologically confirmed adenomas, sessile serrated adenomas and large (>10mm) hyperplastic polyps of the proximal colon (cecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.
8 secondary outcomes
Adenoma Detection Rate (ADR)
Time frame: During procedure
Sessile Serrated Adenomas Per Colonoscopy (SSAPC)
Time frame: During procedure
Sessile Serrated Adenomas Per Colonoscopy* (SSAPC*)
Time frame: During procedure
Neoplastic Polyps Per Colonoscopy (NPPC)
Time frame: During procedure
Large Polyps Per Colonoscopy (PPC)
Time frame: During procedure
Large Adenoma Per Colonoscopy
Time frame: During the procedure
Colonoscope Withdrawal Time of Negative Procedures
Time frame: During procedure
Colonoscope Withdrawal Time
Time frame: During procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41449203Kader 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.
- Meditrial Clinical Research OrganizationLink provided by the sponsor.
- Odin Vision Cloud Connected EndoscopyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Repici, Prof. principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with CADDIE and Standard Colonoscopy in people with Colorectal Cancer and Polyp of Colon, run by Odin Medical at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Poland, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Per Colonoscopy (APC) (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.