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

Last updated: October 20, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Barrett's Esophagus

Esophageal Disorders

Heartburn

Treatment

Experimental OFDI Imaging

Clinical Study ID

NCT02947971
2015-P000587
5R01CA184102-02
  • Ages 14-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 inclusioncriteria 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 onlyclear liquids for 2 hours prior to the procedure.

Exclusion

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 issmaller than the diameter of the capsule.

  • Participants who are pregnant. In case of women of child bearing age, we will askthem if they are pregnant and if unsure; ask them to take a pregnancy test.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Experimental OFDI Imaging
Phase:
Study Start date:
April 15, 2016
Estimated Completion Date:
December 31, 2028

Study Description

Ten healthy participants and ten participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.

The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.

Images of the esophagus will be acquired in real time to be analyzed later.

Connect with a study center

  • Massachusetts General hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

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