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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of NBI on Patients Undergoing Endoscopic Eradication Therapy

NCT03191604

Barrett Esophagus

COMPLETED

NvisionVLE™ Registry System Registry

NCT02215291

Esophagogastroduodenoscopy

COMPLETED

Confocal Laser Probe to Treat Barrett's Esophagus

NCT02852525

Barrett's Esophagus

COMPLETED NA

The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus

NCT02498041

Barrett's Esophagus Dyspepsia

COMPLETED NA

Novel Imaging Techniques in Barrett's Esophagus

NCT00576498

Barrett Esophagus Gastroesophageal Reflux

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Barrett's Esophagus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EGD with 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 following standard of care endoscopy

Group Type OTHER

NvisionVLE with Real Time Targeting

Intervention Type DEVICE

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

esophagogastroduodenoscopy (EGD)

Intervention Type PROCEDURE

Standard of care EGD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

esophagogastroduodenoscopy (EGD)

Standard of care EGD

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients over the age of 18.
* Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
* Ability to provide written, informed consent.
* No significant esophagitis (LA grade \< B, C and D).

Exclusion Criteria

* Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
* Patients without visible BE at time of study EGD.
* Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
* Prior esophageal or gastric surgical resection.
* Significant esophageal stricture requiring dilatation.
* Patients who require anticoagulation for whom biopsy would be contraindicated.
* Patients who are known to be pregnant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No