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Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
RECRUITINGN/ASponsored by Massachusetts General Hospital
Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2016-04-15
Est. completion2026-12
Eligibility
Age14 Years – 85 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT02947971
Summary
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
Age: 14 Years – 85 YearsHealthy volunteers accepted
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.
Conditions2
Barrett's EsophagusCancer
Locations1 site
Massachusetts General hospital
Boston, Massachusetts, 02114
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Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2016-04-15
Est. completion2026-12
Eligibility
Age14 Years – 85 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT02947971