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

Recruiting now · Not applicable

Conditions studied: Barrett's Esophagus

In brief

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.

Key facts

Study ID

NCT02947971

Run by

Massachusetts General Hospital

People needed

120

Starts

2016-04-15

Expected to finish

2028-12-01

Last updated by the study team

2025-10-22

Who can join

Age: 14 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Participants must be able to give informed consent
• Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

You may not qualify if…

• 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.
• Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.

Where it is running

• Massachusetts General hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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