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 volunteersQualifiers
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
Single group
Treatments tested in this trial
EndoAIM
DeviceEndoAIM will be used during the withdrawal process of the colonoscopy
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
The percentage of correct accuracy of measurement
The percentage of correct accuracy of measurement
Proportion of polyps
Proportion of polyps undersized, oversized or accurately sized within 10%
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.
Sponsors and contacts
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