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

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

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).

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.

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.