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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Colorectal Neoplasms; Adenoma Colon Polyp

• Registration Number: NCT07125300
• Lead Sponsor: Javier Santos Fernández

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Study First Submitted: 2025-07-25
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.	During the screening colonoscopy visit (single time point assessment on the day of the procedure).

Secondary Outcome Measures

Name	Time	Method
To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.	During the screening colonoscopy visit (single time point assessment on the day of the procedure).

Trial Locations

Locations (1)

University Care Complex of Palencia; 🇪🇸 Palencia, Spain