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NCT Number: NCT06957015

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

Colorectal polyp size is related to the risk of exhibiting advanced histological features. Moreover, polyps larger than 10 mm are associated with an elevated risk of metachronous advanced neoplasia and colorectal cancer (CRC). Consequently, accurate measurement of polyp size, especially at the 10 mm threshold is critical for risk stratification and surveillance intervals. Furthermore, polyp size is also important for the choice of the appropriate resection procedures. Underestimation may lead to delayed diagnosis, thereby increasing the risk of colorectal cancer, while overestimation may result in unnecessary surveillance endoscopies.

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Key information

About this study

Concerns regarding polyp size measurement are increasing. In daily practice, polyp size is mostly estimated based on visual size estimation by the endoscopist, which has proven to be inaccurate, with reported accuracies ranging from 54% to 65%. Furthermore, a prevalent terminal digit preference has been observed, with clustering of size measurements at 5-mm intervals. Additionally, inappropriate surveillance recommendations based on endoscopists' visual assessment have been documented for up to 35% of polyps. Some endoscopists routinely use non-calibrated instruments such as biopsy forceps or polypectomy snares to improve polyp size estimation. However, this approach has proven to be costly and time-consuming. Besides, endoscopes' fisheye lens can lead to size distortions depending on placement of an instrument in the center or periphery of the endoscope image.

AI-assisted systems, such as Virtual Scale Endoscopy (Fujifilm, Tokyo, Japan) and ENDOANGEL-CPS (Renmin Hospital of Wuhan University, Wuhan, China), have been developed to increase the accuracy of polyp size measurement. However, these systems have primarily been tested in video-based studies, which may not accurately reflect real-time conditions. Recently, a new artificial intelligence system (EndoAIM) has been developed that allows polyp size measurement during real-time endoscopy. This system can automatically estimate the diameter of polyps. Preclinical studies have shown promising performance for EndoAIM, with an overall accuracy of 0.98 in discriminating polyp size at the 10 mm threshold. However, its measurement accuracy has not been tested in real patients during real-time endoscopy.

In this research project, we aim to evaluate the measurement accuracy of EndoAIM for estimating colorectal polyp size in real patients during real-time endoscopy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects are eligible if:

  • They have received colonoscopy for screening, surveillance or symptom investigation;
  • Aged 18 years older or above;
  • Written informed consent obtained.

Exclusion criteria

Subjects are excluded if they have:

  • Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
  • Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
  • Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)

Treatment and study plan

EndoAIM

Device

EndoAIM will be used during the withdrawal process of the colonoscopy

Primary outcomes

  1. The primary endpoint is the difference in percentage for each measurement in discriminating polyp size at the 10mm threshold

    Time frame: During the colonoscopy

    The primary endpoint is the difference in percentage for each measurement in discriminating polyp size at the 10mm threshold

Secondary outcomes

  1. The percentage of correctness of each measurement in discriminating polyp size at the 5 mm threshold

    Time frame: During the colonoscopy

    The percentage of correctness of each measurement in discriminating polyp size at the 5 mm threshold

  2. The percentage of correct accuracy of measurement

    Time frame: During the colonoscopy

    The percentage of correct accuracy of measurement

  3. Proportion of polyps

    Time frame: During the colonoscopy

    Proportion of polyps undersized, oversized or accurately sized within 10%

  4. Proportion of subjects

    Time frame: During the colonoscopy

    Proportion of subjects with change in surveillance intervals due to change in polyp size measurement, according to the US Multi-Society Task Force (USMSTF) guideline.

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Sia, MSc

CONTACT

[email protected]

852-2637-0428

Louis HS Lau, FRCP

CONTACT

[email protected]

26370428

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Acronym: EndoAIM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 4, 2025
Registry last updated
Apr 23, 2026

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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