About this trial
The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
Participants 18 years and older with a previous diagnosis of GERD
Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers)
Health participants over the age of 18 but less than 85 years of age
Disqualifiers
Participants over 85 years of age
Participants with the inability to swallow pills and capsules.
Participants with a strong gag reflex
Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
Trial design
Single group
Treatments tested in this trial
Experimental OFDI Imaging
DeviceImaging of the esophagus with a compact OFDI system and distal scanning catheter
Treatment groups
Trial outcomes
Primary outcomes
Assessment of quality and performance of Compact Imaging System (CIS)
Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator