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AmplifEYE Colonoscopy vs Standard Colonoscopy

NCT03814369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2019-03-26

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

AmplifEYE

AmplifEYE colonoscopy

Sponsors & Collaborators

  • Our Lady of Maryknoll Hospital

    collaborator OTHER

  • Queen Elizabeth Hospital, Hong Kong

    lead OTHER

Principal Investigators

  • Shun Fung Sze, MBBS · Department of Medicine, Queen Elizabeth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-06-30
Completion
2018-11-30
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814369 on ClinicalTrials.gov