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NCT Number: NCT02947971

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

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.

Recruiting

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Key information

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Anita Chung, RN

CONTACT

[email protected]

617-643-6092

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental OFDI Imaging

Device

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

Primary outcomes

  1. Assessment of quality and performance of Compact Imaging System (CIS)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anita Chung, RN

CONTACT

[email protected]

617-724-4515

Juleen Guoy, RN

CONTACT

[email protected]

617-726-5317

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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 dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Oct 28, 2016
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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