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Study to Image the Esophagus Using the OFDI Capsule

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ClinicalTrials.gov Identifier: NCT02204150
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : April 23, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Eosinophilic Esophagitis Device: OFDI Capsule Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
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
Actual Study Start Date : February 2012
Actual Primary Completion Date : July 31, 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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 ]
    Number of subjects from whom the quality OFDI imaging was obtained


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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
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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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
More Information
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Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02204150    
Other Study ID Numbers: 2011P002619
5R01CA103769-07 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2014    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Optical Coherence Tomography
Barrett's Esophagus
Esophagus
Imaging
Additional relevant MeSH terms:
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Barrett Esophagus
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Precancerous Conditions
 Neoplasms
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases