Study to Image the Esophagus Using the OFDI Capsule
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ClinicalTrials.gov Identifier: NCT02204150 |
Recruitment Status
:
Recruiting
First Posted
: July 30, 2014
Last Update Posted
: January 25, 2018
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Condition or disease | Intervention/treatment | Phase |
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Barrett's Esophagus Eosinophilic Esophagitis | Device: OFDI Capsule | Phase 1 |
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 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 |

Arm | Intervention/treatment |
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Experimental: OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
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Device: OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
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- 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.
- 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.

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

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
Contact: Guillermo Tearney, MD., PhD | 617-724-2979 | gtearney@partners.org | |
Contact: Mireille Rosenberg, PhD | 617-726-9145 | mrosenberg@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Norman Nishioka, MD 617-726-4422 nnishioka@partners.org |
Principal Investigator: | Guillermo Tearney, MD., PhD | Massachusetts General Hospital |
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 |