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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

They have received colonoscopy for screening, surveillance or symptom investigation;

Aged 18 years older or above;

Written informed consent obtained.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • EndoAIM

    Device

    EndoAIM will be used during the withdrawal process of the colonoscopy

Treatment groups

278 Participants
are divided into 1 treatment group
Group A: ENDOAIM used armExperimental treatment 1 intervention

Trial outcomes

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

Time frame
During the colonoscopy

Secondary outcomes

1

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

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

Time frame
During the colonoscopy
2

The percentage of correct accuracy of measurement

The percentage of correct accuracy of measurement

Time frame
During the colonoscopy
3

Proportion of polyps

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

Time frame
During the colonoscopy
4

Proportion of subjects

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.

Time frame
During the colonoscopy

Other outcomes

Sponsors and contacts

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