ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Image the Esophagus Using the OFDI Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02204150
Recruitment Status : Recruiting
First Posted : July 30, 2014
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI) screening probe in healthy subjects, patients with Barrett's Esophagus and Eosinophilic Esophagitis.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Eosinophilic Esophagitis Device: OFDI Capsule Phase 1

Detailed Description:

A total of 54 subjects comprising of healthy volunteers, patients with Eosinophilic Esophagitis (EoE) or Barrett's Esophagus 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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
Study Start Date : February 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.


Secondary Outcome Measures :
  1. Tolerability 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 ]
    After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204150


Contacts
Contact: Guillermo Tearney, MD., PhD 617-724-2979 gtearney@partners.org
Contact: Mireille Rosenberg, PhD 617-726-9145 mrosenberg@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Norman Nishioka, MD    617-726-4422    nnishioka@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02204150     History of Changes
Other Study ID Numbers: 2011P002619
5R01CA103769-07 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Optical Coherence Tomography
Barrett's Esophagus
Esophagus
Imaging

Additional relevant MeSH terms:
Esophagitis
Barrett Esophagus
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Digestive System Abnormalities
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases