Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT06059378

Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps

Led by Daniel Von Renteln · Updated on 2025-02-19

204

Participants Needed

1

Research Sites

95 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard. The primary aim of this study is to show the accuracy of intracolonoscopy AI-assisted optical diagnosis (CADx; autonomous or with human input) when the AI-assisted optical diagnosis made by the expert endoscopists is used as the reference standard. The specific aims are: 1. To evaluate the accuracy of intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) by comparing it to the obtained optical histology diagnoses provided by two independent expert endoscopists as the reference standard. 2. To evaluate the agreement between the intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) and the AI-assisted optical diagnosis performed by two independent expert endoscopists. 3. To determine whether AI-assisted optical polyp diagnosis for diminutive (1-5 mm) polyps can be implemented in routine clinical practice by demonstrating that at least 70% of the approached patients are interested in undergoing AI-assisted optical diagnosis (autonomous or with human input). 4. To evaluate the cost savings resulting from replacing pathology with AI-assisted optical diagnosis.

CONDITIONS

Official Title

Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45-80 years
  • Undergoing an outpatient colonoscopy at the Centre Hospitalier de l'Universit�e9 de Montr�e9al (CHUM)
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Inflammatory Bowel Disease
  • Active colitis
  • Hereditary colorectal cancer syndrome
  • Coagulopathy
  • American Society of Anesthesiologists (ASA) status >3

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Using AI-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps | DecenTrialz