RECRUITING

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

Description

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 subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Conditions

Barrett's Esophagus
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Related Conditions:

Barrett's Esophagus

Study Overview

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Study Details

Study overview

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 subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System

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

Condition
Barrett's Esophagus
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
  • * Subjects must be over the age of 18 but less than 70 year of age.
  • * Subjects must be able to give informed consent
  • * Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
  • * Subjects over 70 years of age
  • * Subjects with the inability to swallow pills and capsules.
  • * Subjects with a strong gag reflex
  • * Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
  • * Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Massachusetts General Hospital,

Guillermo Tearney, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2027-12