A Study of Conforcal Fluorescent Microscopy in Barrett's Esophagus Tissue from Clinically-Indicated Endoscopic Resection
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
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.
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.
The study inclusion criteria include patients who are:
- Undergoing clinically-indicated endoscopy for Barrett’s esophagus-related neoplasia
- Over 18 years of age
- Able to provide informed consent.
The study exclusion criteria include human subjects who are:
- Known to have a bleeding disorder (INR > 1.5) as this is a clinical contraindication to endoscopic mucosal resection
- Unable to tolerate endoscopy
- Women of childbearing age (menstrual period in the past three months)
- Severely-ill who are unsafe for routine endoscopy (i.e. on-going heart failure, difficulty breathing, and acute kidney failure)
Publications are currently not available