Use of AmplifEYE-assisted Colonoscopy Compared to Standard Colonoscopy in Polyp and Adenoma Detection

Queen Elizabeth Hospital, Hong Kong1 site in 1 country355 target enrollmentMarch 1, 2017

ConditionsColon Polyp Adenoma Colon Serrated Polyp Colonic Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colon Polyp
Sponsor: Queen Elizabeth Hospital, Hong Kong
Enrollment: 355
Locations: 1
Primary Endpoint: Adenoma detection rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.

Detailed Description

This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All study team members will have a prior run-in phase of performing at least 5 AmplifEYE colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.

Registry

clinicaltrials.gov

Start Date

March 1, 2017

End Date

November 30, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel