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Clinical Trials/NCT05139186
NCT05139186
Completed
Not Applicable

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

Istituto Clinico Humanitas1 site in 1 country1,120 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Artificial Intelligence
Sponsor
Istituto Clinico Humanitas
Enrollment
1120
Locations
1
Primary Endpoint
Adenoma per colonoscopy (APC)
Status
Completed
Last Updated
last year

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 10, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients aged 45 or older undergoing average risk colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater).

Exclusion Criteria

  • subjects with personal history of CRC, or IBD.
  • subjects affected with Lynch syndrome or Familiar Adenomatous Polyposis.
  • patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \< 2 in any colonic segment).
  • patients with previous colonic resection.
  • patients on antithrombotic therapy, precluding polyp resection.
  • patients who were not able or refused to give informed written consent.

Outcomes

Primary Outcomes

Adenoma per colonoscopy (APC)

Time Frame: 9 Months

APC, defined as the total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies.

Secondary Outcomes

  • Positive predictive value (PPV)(9 Months)

Study Sites (1)

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