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Study to Image the Esophagus Using the OFDI Capsule
This study is currently recruiting participants.
Verified October 2016 by Guillermo Tearney, Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02204150
First received: June 12, 2014
Last updated: October 26, 2016
Last verified: October 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Barrett's Esophagus Eosinophilic Esophagitis | Device: OFDI Capsule | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Guillermo Tearney, Massachusetts General Hospital:
Primary Outcome Measures:
- 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:
- 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.
| Estimated Enrollment: | 54 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02204150
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 ) |
| Study First Received: | June 12, 2014 |
| Last Updated: | October 26, 2016 |
| 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 |
ClinicalTrials.gov processed this record on September 21, 2017