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A Study Comparing Standard and AI-Assisted Colonoscopies for Detecting and Characterizing Colorectal Lesions in Adults Aged 50-74 Undergoing Cancer Screening

NCT07125300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2025-08-15

No results posted yet for this study

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.

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

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence-Assisted Colonoscopy

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.

Sponsors & Collaborators

  • Javier Santos Fernández

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125300 on ClinicalTrials.gov