Home › Barrett Esophagus › NCT02947971
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
Who can join
Ages 14 to 85 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- Experimental OFDI Imaging (device)
Sponsor: Massachusetts General Hospital · Participants: 120 · Started: Apr 15, 2016
Contact the study team
- Juleen Guoy, RN · Phone: 617-726-5317
- Anita Chung, RN · Phone: 617-724-4515
Official record on ClinicalTrials.gov — NCT02947971
Locations in the U.S.
| Massachusetts | Massachusetts General hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.