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

NCT06957015 | Recruiting DMC

• 1 other identifier: 2024.608
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonic Polyps; CRC (Colorectal Cancer); Artificial Intelligence (AI)

Keywords

artificial intelligence; polyp size measurement; surveillance intervals

Outcome Measures

Primary Outcomes (1)

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

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

  During the colonoscopy

Secondary Outcomes (4)

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

  During the colonoscopy

• The percentage of correct accuracy of measurement

  During the colonoscopy

• Proportion of polyps

  During the colonoscopy

• Proportion of subjects

  During the colonoscopy

Study Arms (1)

ENDOAIM used arm

EXPERIMENTAL

ENDOAIM will be used during withdrawal phase of colonoscopy

Device: EndoAIM

Interventions

EndoAIM DEVICE

EndoAIM will be used during the withdrawal process of the colonoscopy

ENDOAIM used arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Louis HS Lau, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis HS Lau, FRCP

CONTACT

26370428; louishslau@cuhk.edu.hk

Felix Sia, MSc

CONTACT

852-2637-0428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Endoscopists will be blinded from EndoAIM's AI generated results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will undergo standard bowel preparation before elective colonoscopy. Patients who are on antithrombotics will be instructed to withhold the medication before procedure according to clinical conditions. Baseline demographics and patient characteristics will be recorded.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 4, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)