Last reviewed · How we verify
NCT07125300
A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening
NA trial testing Artificial Intelligence-Assisted Colonoscopy in Colorectal Neoplasms in 368 participants. Completed in 28 February 2025.
28 February 2025
Quick facts
| Lead sponsor | Javier Santos Fernández |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 368 |
| Start date | 1 October 2023 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Artificial Intelligence-Assisted Colonoscopy
Conditions studied
- Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Adenoma Colon Polyp — all drugs for Adenoma Colon Polyp →
Sponsor
Javier Santos Fernández
Who can join
Adults 50 to 74, any sex, with Colorectal Neoplasms or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Robles de la Osa D, Santos Fernández J, Pérez Urra C, Espinel Pinedo P, et al · · 2026 · PMID 41854124 · DOI 10.1111/codi.70426
Verify or expand the search:
- PubMed search for NCT07125300
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07125300 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Javier Santos Fernández
- Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07125300.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing