Clinical trial · Interventional
A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening
Efficacy of an Artificial Intelligence System for Lesion Detection and Characterization (CADe and CADx) During Colorectal Cancer Screening Colonoscopies: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma Colon Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence-Assisted Colonoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional colonoscopy without AI assistance
- type
- EXPERIMENTAL
- label
- AI-assisted colonoscopy
- interventionNames
- Diagnostic Test: Artificial Intelligence-Assisted Colonoscopy
Primary outcomes (1)
- measure
- To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.
- timeFrame
- During the screening colonoscopy visit (single time point assessment on the day of the procedure).
Secondary outcomes (1)
- measure
- To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Incomplete colonoscopy (e.g., failure to reach the cecum) * Inadequate bowel preparation * History of colorectal surgery * Inability to provide informed consent
References
Publications (1)
- DERIVEDRobles 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. PMID 41854124