Study to Image the Esophagus Using the OFDI Capsule

April 22, 2019 updated by: Guillermo Tearney, Massachusetts General Hospital

Pilot Study for Imaging of the Esophagus Using an OFDI Capsule

The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A previous diagnosis of Barrett's Esophagus
  • OR a previous diagnosis of EoE
  • OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
  • Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
  • Subject must be able to give informed consent

Exclusion Criteria:

  • Subjects with known esophageal strictures, intestinal strictures or dysphagia
  • OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Device: OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Number of subjects from whom the quality OFDI imaging was obtained
Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

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

Investigators

  • Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

July 31, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P002619
  • 5R01CA103769-07 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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