NCT07125300Completed
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 · Last updated 15 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 368 (actual)
- First submitted
- 25 Jul 2025
- Start date
- 1 Oct 2023
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Javier Santos Fernández
- Diseases
- Colorectal cancer
- NCT number
- NCT07125300
What you commit to
- Study type: Interventional
- Participants enrolled: 368
- From 1 Oct 2023 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Incomplete colonoscopy (e.g., failure to reach the cecum)
- History of colorectal surgery
Other
- Inadequate bowel preparation
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 50 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Care Complex of Palencia Coordinator of this site? Confirm its status | Palencia | Spain | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.