A Study of Conforcal Fluorescent Microscopy in Barrett's Esophagus Tissue from Clinically-Indicated Endoscopic Resection


Sponsor Protocol Number: 11-006628

About this study

The purpose of this study is to test the performance characteristics of Optiscan, a handheld confocal fluorescent microscopy system, along with Ninepoint and Cellvizeo a probe based confocal microscopy system in ex-vivo Barrett’s esophagus tissue obtained from clinically-indicated, endoscopic mucosal resection (EMR) in patients scheduled for clinically indicated surveillance of Barrett's Esophagus.

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:    

The study inclusion criteria include patients who are:

  1. Undergoing clinically-indicated endoscopy for Barrett’s esophagus-related neoplasia
  2. Over 18 years of age
  3. Able to provide informed consent.   

Exclusion Criteria:   

The study exclusion criteria include human subjects who are:

  1. Known to have a bleeding disorder (INR > 1.5) as this is a clinical contraindication to endoscopic mucosal resection
  2. Unable to tolerate endoscopy
  3. Women of childbearing age (menstrual period in the past three months)
  4. Severely-ill who are unsafe for routine endoscopy (i.e. on-going heart failure, difficulty breathing, and acute kidney failure)

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