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Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System

NCT02864043 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-03-04

No results posted yet for this study

Summary

The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).

Conditions

  • Barrett's Esophagus

Interventions

DEVICE

NvisionVLE with Real Time Targeting

Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe

PROCEDURE

esophagogastroduodenoscopy (EGD)

Standard of care EGD

Sponsors & Collaborators

  • NinePoint Medical

    lead INDUSTRY

Principal Investigators

  • Kenneth Wang, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-06-01
Completion
2020-06-01

Countries

  • United States

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 NCT02864043 on ClinicalTrials.gov