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

RecruitingNAAges 14 Years - 85 YearsAllMassachusetts General Hospital
NCT02947971 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Experimental OFDI Imaging
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Where

1 site
Massachusetts General hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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