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

Massachusetts General Hospital · with National Institutes of Health (NIH), National Cancer Institute (NCI) · NCT02947971

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 14–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
120
US sites recruiting
1
Study start
April 15, 2016
Record last updated
October 22, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Experimental OFDI Imaging

Conditions: Barrett's Esophagus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Massachusetts General hospital

    Boston, MA 02114

    Site contact: Anita Chung, RN · 617-643-6092 · Tearneylabtrials@partners.org

Study contacts (from the official record)

  • Juleen Guoy, RN · 617-726-5317 · Tearneylabtrials@partners.org
  • Anita Chung, RN · 617-724-4515 · Tearneylabtrials@partners.org
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Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule… (NCT02947971) | Bored Studies