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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04260321
Enrollment
700
Registered
2020-02-07
Start date
2020-02-19
Completion date
2020-12-31
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Artificial Intelligence

Brief summary

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.

Interventions

DEVICEAI

Artificial intelligence colonoscopy

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Non-inferiority of AI-aided colonoscopy in terms of ADR5 MonthsThe proportion of participants with at least one adenoma (per-patient analysis).

Countries

Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026