Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06957015

A Prospective Study to Evaluate the Performance of a Real-time System in the Estimation of Colorectal Polyp Size

Led by Chinese University of Hong Kong · Updated on 2026-04-23

278

Participants Needed

1

Research Sites

35 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy of a new artificial intelligence system called EndoAIM for measuring colorectal polyp size during real-time endoscopy. Accurate measurement of polyp size, especially at the 10 mm threshold, is important for assessing the risk of advanced neoplasia and colorectal cancer, as well as deciding the best removal method. Current visual estimates by doctors can be inaccurate, leading to risks of delayed diagnosis or unnecessary procedures. In this study, EndoAIM will be used during the withdrawal phase of colonoscopy procedures to automatically estimate polyp diameters. This device aims to improve measurement accuracy compared to visual estimates or non-calibrated tools. The study focuses on real patients undergoing colonoscopy, assessing EndoAIM’s performance in real-time clinical settings. Participants will undergo colonoscopy with EndoAIM used to measure polyps during the procedure. Researchers will compare measurement accuracy at 10 mm and 5 mm thresholds and evaluate the correctness of size estimations. The primary outcome is the difference in percentage accuracy at the 10 mm threshold during colonoscopy. Secondary outcomes include accuracy at the 5 mm threshold and the proportion of polyps and subjects measured correctly. The study includes adults aged 18 and older and involves monitoring during the colonoscopy procedure.

CONDITIONS

Brief Title

A Prospective Study to Evaluate the Performance of a Real-time System in the Estimation of Colorectal Polyp Size

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Have received colonoscopy for screening, surveillance, or symptom investigation
  • Aged 18 years or older
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Contraindication to colonoscopy such as intestinal obstruction or perforation
  • Contraindication or conditions preventing polyp removal, including active gastrointestinal bleeding or uninterrupted anticoagulation or dual antiplatelet therapy
  • Advanced medical conditions classified as American Society of Anesthesiologists grade 4 or above

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of colonoscopy procedure

Participants undergo colonoscopy during which the EndoAIM device is used in real-time to estimate colorectal polyp size during the withdrawal phase.

1 procedure visit (in-person)

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Shatin, Hong Kong

Actively Recruiting

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Research Team

L

Louis HS Lau, FRCP

F

Felix Sia, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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