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

Overview

About this study

The purpose of this study is to evaluate the performance of the NvisionVLE® Imaging System for determining features of dysplastic Barrett's Esophagus by collection and analysis of medical record information, imaging data, and pathology results. The study is for patients who have a prior biopsy-confirmed diagnosis of Barrett's esophagus with dysplasia and are scheduled to have an endoscopic evaluation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Over the age of 18
  • Is undergoing an upper endoscopy for Barrett's Esophagus surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD)
  • Able to provide written, informed consent
  • No significant esophagitis (LA grade < B, C and D)

Exclusion Criteria

  • Has achieved complete remission of intestinal metaplasia (CR-IM)
  • Is without visible BE at time of study EGD
  • 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
  • Requires anticoagulation (biopsy would be contraindicated)
  • Known to be pregnant

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20265561

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