Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System (NCT02947971) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
United States120 participantsStarted 2016-04-15
Plain-language 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.
Who can participate
Age range14 Years – 85 Years
SexALL
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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.
What they're measuring
1
Assessment of quality and performance of Compact Imaging System (CIS)