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OpenTrials
Completed

NCT Number: NCT04260321

The AID Study 2: Artificial Intelligence for Colorectal Adenoma Detection 2

Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back" colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC.

Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy.

Average experienced endoscopists (each having performed <2000 screening colonoscopies) will perform the endoscopic procedure.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Poliambulanza, Brescia, Italia, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All 40-80 years-old subjects undergoing a colonoscopy

Exclusion criteria

  • subjects with personal history of CRC, or IBD.
  • 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

AI

Device

Artificial intelligence colonoscopy

Primary outcomes

  1. Non-inferiority of AI-aided colonoscopy in terms of ADR

    Time frame: 5 Months

    The proportion of participants with at least one adenoma (per-patient analysis).

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Feb 5, 2021

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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