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The EYE Study Enhancing the Diagnostic Yield of Standard Colonoscopy by Artificial Intelligence Aided Endoscopy

NCT05139186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1120

Last updated 2024-08-06

No results posted yet for this study

Summary

Colorectal cancer (CRC) remains one of the leading causes of mortality among neoplastic diseases in the world\[1\] . Adequate colonoscopy based CRC screening programs have proved to be the key to reduce the risk of mortality, by early diagnosis of existing CRC and detection of pre-cancerous lesions\[2-4\] . Nevertheless, long-term effectiveness of colonoscopy is influenced by a range of variables that make it far from a perfect tool\[5\]. The effectiveness of a colonoscopy mainly depends on its quality, which in turn is dependent on the skill and expertise of the endoscopist. In fact, several studies have shown a significant adenoma miss rate of 24%-35%, especially in patients with diminutive adenomas\[6,7\] . These data are in line with interval cancers incidence (I-CRC), defined as the percentage of cancers diagnosed after a screening program and before the intended surveillance duration, of approximately 3%-5% \[8,9\].

The development of the artificial intelligence (AI) applications in the medical field has grown in interest in the past decade. Its performance on increasing automatic polyp and adenoma detection has shown promising results in order to achieve an higher ADR\[10\]. The use of computer aided diagnosis (CAD) for detection of polyps had initially been studied in ex vivo studies but in the last few years, with the advancement in computer aided technology and emergence of deep learning algorithms, use of AI during colonoscopy has been achieved and more studies have been undertaken \[10\].

Recently Fujifilm (Tokyo, Japan) has developed a new technology known as "CAD-EYE" aiming to support both colonic polyp detection and characterization during colonoscopy. This technology is now available in Europe, being compatible with the latest generation of Fujifilm endoscopes (ELUXEO Fujifilm Co.).

However, the clinical impact of CAD-EYE system in improving the adenoma detection have yet to be assessed

Conditions

  • Artificial Intelligence

Interventions

DEVICE

Artificial Intelligence

Artificial intelligence

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-31
Completion
2023-10-10

Countries

  • Italy

Study Locations

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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 NCT05139186 on ClinicalTrials.gov