NCT02864043

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

Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: NinePoint Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed. This Study is designed 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). The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA). Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2016-08-11
• Last updated: 2020-03-04

Locations

5 sites across 1 country: United States