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OpenTrials
Completed

NCT Number: NCT05141409

The COMBO CAD Study

Implementation of clinical strategies based on optical diagnosis of <5 mm colorectal polyps may lead to a substantial saving of economic and financial resources. Despite this, 84.2% of European endoscopists reported not to use such strategies - also named as leave-in situ and resect- and-discard - in their practice due to the fear of an incorrect optical diagnosis.

Indeed, accuracy of optical diagnosis is operator-dependent, and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice.

Artificial intelligence (AI) is being increasingly explored in different domains of medicine, particularly those entailing image analysis. As optical diagnosis involves subitaneous processing of multiple images, searching for specific visual clues, and recognizing well-defined visual patterns, AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps, making the characterization process more reliable and objective. Computer-Aided-Diagnosis systems aiming at characterization are called CADx.

Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp, and initial experiences in clinical practice confirmed preliminary results.

To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy, we exploited two new Computer-Aided-Diagnosis systems (CAD-EYE® Fujifilm Co., and GI-Genius® Medtronic) that provide the endoscopist with a real-time polyp characterization without the need of optical magnification.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients aged 40 or older undergoing a colonoscopy for gastrointestinal symptoms, fecal immunohistochemical test positivity, primary screening or post-polypectomy surveillance

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.

Treatment and study plan

Artificial intelligence

Device

Artificial Intelligence

Primary outcomes

  1. AI-assisted optical diagnosis performance

    Time frame: 6 Months

    AI-assisted optical diagnosis performance

Secondary outcomes

  1. AI alone optical diagnosis performance

    Time frame: 6 Months

    AI alone optical diagnosis performance

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

The COMBO CAD Study: Characterization cOMparison Between twO CAD Systems

Acronym: COMBO-CAd

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Dec 29, 2022

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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