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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

14 years - 85 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

120 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Massachusetts General Hospital

Study start

Apr 15, 2016 Actual

Primary completion

2028-12 Estimated

Study completion

2030-12 Estimated

First posted

Oct 28, 2016 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts