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RECRUITINGINTERVENTIONAL

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

Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Experimental OFDI Imaging

Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Locations (1)

Massachusetts General hospital
Boston, Massachusetts, United States