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

Mass General Brigham

Status

Enrolling

Conditions

Barrett's Esophagus

Treatments

Device: Experimental OFDI Imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02947971

2015-P000587

5R01CA184102-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

14 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.