AmplifEYE Colonoscopy vs Standard Colonoscopy

Not Applicable

Completed

• Conditions: Adenoma Colon; Colonic Neoplasms; Colon Polyp; Serrated Polyp
• Interventions: Device: AmplifEYE

• Registration Number: NCT03814369
• Lead Sponsor: Queen Elizabeth Hospital, Hong Kong

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-11-30
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-24
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Aged between 50 to 79 years old
• Scheduled for screening, surveillance or diagnostic colonoscopy

Exclusion Criteria

• Colonic strictures
• History of bowel surgery
• Per-rectal bleeding within six weeks
• Inflammatory bowel disease
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AmplifEYE colonoscopy	AmplifEYE	Colonoscopy performed with AmplifEYE equipped

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	1 day	number of patients in whom at least one adenoma could be found

Secondary Outcome Measures

Name	Time	Method
caecal intubation rate	1 day	number of patients in whom caecal intubation is acheived
caecal intubation time	1 day	time beginning with the insertion of the colonoscope until reaching the caecum
Polyp detection rate	1 day	number of patients in whom at least one polyp could be found
Serrated polyp detection rate	1 day	number of patients in whom at least one serrated polyp could be found

Trial Locations

Locations (1)

Department of Medicine, Queen Elizabeth Hospital; 🇭🇰 Hong Kong, Hong Kong