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

Status unconfirmed · Not applicable

Conditions studied: Barrett's Esophagus

In brief

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).

Key facts

Study ID

NCT02864043

Run by

NinePoint Medical

People needed

150

Starts

2016-09-01

Expected to finish

2020-06-01

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UC Irvine Medical Center — Irvine, California, United States
• VA Boston — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• North Shore University Hospital — Manhasset, New York, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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