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NCT Number: NCT07125300

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

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.

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Key information

Conditions

Colorectal Neoplasms Adenoma Colon Polyp Colonic Diseases Colorectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Care Complex of Palencia

Palencia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial Intelligence-Assisted Colonoscopy

Diagnostic Test

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.

Primary outcomes

  1. To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy.

    Time frame: During the screening colonoscopy visit (single time point assessment on the day of the procedure).

Secondary outcomes

  1. To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy.

    Time frame: During the screening colonoscopy visit (single time point assessment on the day of the procedure).

Sponsors and collaborators

Lead sponsor

Javier Santos Fernández

Other

Registry information

Official study title

Efficacy of an Artificial Intelligence System for Lesion Detection and Characterization (CADe and CADx) During Colorectal Cancer Screening Colonoscopies: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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