Colorectal NeoplasmsNCT07125300
A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening
A study testing Artificial Intelligence-Assisted Colonoscopy in people with Colorectal Neoplasms and Colorectal Cancer, run by Javier Santos Fernández at 1 site in Spain.
Trial summary
The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer, Adenoma Colon Polyp
- What is being tested?
- Artificial Intelligence-Assisted Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 50 to 74 years
- Positive fecal immunochemical test (FIT) result (≥100 ng/mL)
- Scheduled for screening colonoscopy within a population-based colorectal cancer screening program
- Able and willing to provide written informed consent
Who cannot join
- Incomplete colonoscopy (e.g., failure to reach the cecum)
- Inadequate bowel preparation
- History of colorectal surgery
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Artificial Intelligence System for Lesion Detection and Characterization (CADe and CADx) During Colorectal Cancer Screening Colonoscopies: A Randomized Clinical Trial
The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test.
The main questions it aims to answer are:
Read more
- Does AI assistance increase the detection of adenomas or advanced colorectal neoplasia?
- Does AI provide more accurate optical diagnosis of polyps compared to standard assessment by endoscopists?
Researchers will compare colonoscopies performed with AI assistance (using the CAD EYE™ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy.
Participants will:
- Undergo a screening colonoscopy after a positive fecal immunochemical test (FIT)
- Be randomly assigned to either an AI-assisted or standard colonoscopy group
- Have any detected polyps removed and analyzed
- Receive either AI-based or physician-based optical diagnosis of polyps during the procedure
This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Adenoma Colon Polyp
- Being tested
- Artificial Intelligence-Assisted Colonoscopy
- Keywords
- Colorectal cancer screening, Colonoscopy, Artificial Intelligence, CADe, CADx
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Assisted ColonoscopyDiagnostic test
The intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions:
- CADe (Computer-Aided Detection): Highlights suspected lesions in real time on the endoscopic video to assist in identifying polyps.
- CADx (Computer-Aided Diagnosis): Provides real-time optical histology predictions to help distinguish between hyperplastic and adenomatous polyps.
The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional colonoscopy without AI assistance | No intervention | Not described |
| AI-assisted colonoscopy | Experimental | Not described Receives: Diagnostic Test: Artificial Intelligence-Assisted Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.
Measured: During the screening colonoscopy visit (single time point assessment on the day of the procedure).
Secondary outcomes (1)
To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.
Measured: During the screening colonoscopy visit (single time point assessment on the day of the procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Oct 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Santos Fernández
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier Santos Fernández, University Care Complex of Palencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125300
- Sponsor's protocol ID
- 2024/023
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robles de la Osa D, Santos Fernandez J, Perez Urra C, Espinel Pinedo P, Bulnes Labrador CB, Martin Ibanez C, Gonzalez de Castro E, Perez Citores L, Montero Moreton AM, Santos Santamarta F, Cimavilla Roman M, Moreira da Silva BA, Maestro Antolin S, Barcenilla Laguna J, Rancel Medina FJ, Rizzo Rodriguez MA, Lopez Allue L, Perez Millan AG. Efficacy of an artificial intelligence system for lesion detection and characterization (CADe and CADx) during colonoscopy following positive faecal immunochemical test in a colorectal cancer screening programme: A randomized clinical trial. Colorectal Dis. 2026 Mar;28(3):e70426. doi: 10.1111/codi.70426.
PubMed 41854124
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Artificial Intelligence System for Lesion Detection and Characterization (CADe and CADx) During Colorectal Cancer Screening Colonoscopies: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07125300
- Acronym / sponsor ID
- 2024/023
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Adenoma Colon Polyp
- Keywords
- Colorectal cancer screening, Colonoscopy, Artificial Intelligence, CADe, CADx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Javier Santos FernándezUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test.
The main questions it aims to answer are:
- Does AI assistance increase the detection of adenomas or advanced colorectal neoplasia?
- Does AI provide more accurate optical diagnosis of polyps compared to standard assessment by endoscopists?
Researchers will compare colonoscopies performed with AI assistance (using the CAD EYE™ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy.
Participants will:
- Undergo a screening colonoscopy after a positive fecal immunochemical test (FIT)
- Be randomly assigned to either an AI-assisted or standard colonoscopy group
- Have any detected polyps removed and analyzed
- Receive either AI-based or physician-based optical diagnosis of polyps during the procedure
This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional colonoscopy without AI assistance | No intervention | – |
| AI-assisted colonoscopy | Experimental | Diagnostic Test: Artificial Intelligence-Assisted Colonoscopy |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 50 to 74 years
- Positive fecal immunochemical test (FIT) result (≥100 ng/mL)
- Scheduled for screening colonoscopy within a population-based colorectal cancer screening program
- Able and willing to provide written informed consent
Key exclusion criteria (4 listed)
- Incomplete colonoscopy (e.g., failure to reach the cecum)
- Inadequate bowel preparation
- History of colorectal surgery
- Inability to provide informed consent
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 |
|---|---|---|
| Artificial Intelligence-Assisted ColonoscopyThe intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions: * CADe (Computer-Aided Detection): Highlights suspected lesions in real time on the endoscopic video to assist in identifying polyps. * CADx (Computer-Aided Diagnosis): Provides real-time optical histology predictions to help distinguish between hyperplastic and adenomatous polyps. The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions. | Diagnostic test | AI-assisted colonoscopy |
Primary outcome
To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.
Time frame: During the screening colonoscopy visit (single time point assessment on the day of the procedure).
1 secondary outcome
To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.
Time frame: During the screening colonoscopy visit (single time point assessment on the day of the procedure).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 41854124Robles de la Osa D, Santos Fernandez J, Perez Urra C, Espinel Pinedo P, Bulnes Labrador CB, Martin Ibanez C, Gonzalez de Castro E, Perez Citores L, Montero Moreton AM, Santos Santamarta F, Cimavilla Roman M, Moreira da Silva BA, Maestro Antolin S, Barcenilla Laguna J, Rancel Medina FJ, Rizzo Rodriguez MA, Lopez Allue L, Perez Millan AG. Efficacy of an artificial intelligence system for lesion detection and characterization (CADe and CADx) during colonoscopy following positive faecal immunochemical test in a colorectal cancer screening programme: A randomized clinical trial. Colorectal Dis. 2026 Mar;28(3):e70426. doi: 10.1111/codi.70426.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Assisted Colonoscopy in people with Colorectal Neoplasms and Colorectal Cancer, run by Javier Santos Fernández at 1 site in Spain.
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 4 inclusion and 4 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 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy. (time frame: During the screening colonoscopy visit (single time point assessment on the day of the procedure).). 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 NCT07125300, 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 15 Aug 2025.