Pilot Study for OFDI Imaging of the Esophagus

This study is testing a new way to image (take pictures of) the esophagus (the tube connecting your mouth to your stomach) using a device called an OFDI (Optical Frequency Domain Imaging) capsule. This capsule is attached to a string and helps doctors see inside your esophagus. The goal is to see how well this new compact imaging system works, how easy it is to use, and if it's safe for people with Barrett's Esophagus (a condition where the lining of the esophagus changes) and healthy volunteers. We are looking for 10 healthy participants and 10 participants with Barrett's Esophagus, aged 14 to 85 years old. The main goal is to check the quality and performance of the imaging system during a 5-7 minute imaging session. The current recruitment status is unclear.

Study design
This is an interventional study involving 20 participants (10 healthy, 10 with Barrett's Esophagus). It is a pilot study, meaning it's an initial test of the new imaging system.
What's involved
You would undergo imaging of your esophagus with the OFDI capsule, which involves the capsule being guided down your esophagus while images are acquired in real time.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 5-7 minutes of imaging, suggesting a short follow-up period during the imaging session itself.

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NCT02947971

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

Recruiting
NAAges 14–85Interventional
Massachusetts General Hospital
~120 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Experimental OFDI Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of quality and performance of Compact Imaging System (CIS)
Measured over 5-7 Minutes of imaging
Barrett's Esophagus
1 sites across 1 states
Massachusetts1
  • Guillermo Tearney, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

Participants 18 years and older with a previous diagnosis of GERD
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

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.
  • Assessment of quality and performance of Compact Imaging System (CIS)5-7 Minutes of imaging

    Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system