NCT03814369

AmplifEYE Colonoscopy vs Standard Colonoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Queen Elizabeth Hospital, Hong Kong · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colon Polyp
• Adenoma Colon
• Serrated Polyp
• Colonic Neoplasms

Interventions

Type	Name	Description
DEVICE	AmplifEYE	AmplifEYE colonoscopy

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-06-30
• Completion: 2018-11-30
• First posted: 2019-01-24
• Last updated: 2019-03-26

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study