The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.
Loma Linda University Medical Center
Loma Linda, California, United States
Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
ADR is calculated by dividing the total number of screening procedures in which 1 or more histologically confirmed adenomas were detected by the total number of screening procedures performed.
Time frame: 1 week
ADR will be differentiated according to morphology
ADR will be differentiated according to morphology (flat, sessile, pedunculated)
Time frame: 1 week
ADR will be differentiated according to final pathology
ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas)
Time frame: 1 week
ADR will be differentiated according to location
Location will be specified by colon segment and flexures.
Time frame: 1 week
Advanced ADR
calculated as same for ADR, but only in those with polyps that are \>=1 cm in size, with components of villous features, or with those of dysplasia
Time frame: 1 week
Mean total number of polyps detected
calculated by dividing the total number of adenomas detected by the total number of screening procedures performed
Time frame: 1 week
ADR-plus
mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
APP (adenomas per positive participant)
calculated as the total number of adenomas detected during the first colonoscopy divided by the number of positive participants (those with ≥1 adenoma detected during the first colonoscopy)
Time frame: 1 week
APC (adenomas per colonoscopy)
calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies
Time frame: 1 week
Quality metrics: time of colonoscopy
Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.
Time frame: 1 hour
Quality metrics: prep quality
Differences in prep quality will be noted
Time frame: 1 hour
Sedative Medications used
Differences in sedative medications used
Time frame: 1 hour