Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-85
SponsorMassachusetts General Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Experimental OFDI Imaging

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator