Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
NCT ID: NCT02947971
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2016-04-15
2028-12-31
Brief Summary
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Detailed Description
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The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.
Images of the esophagus will be acquired in real time to be analyzed later.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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OFDI Imaging
Experimental OFDI Imaging
Experimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Interventions
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Experimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Eligibility Criteria
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Inclusion Criteria
* Health participants over the age of 18 but less than 85 years of age
* Participants must be able to give informed consent
* Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Exclusion Criteria
* Participants with the inability to swallow pills and capsules.
* Participants with a strong gag reflex
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
* Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.
14 Years
85 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Guillermo Tearney
Professor of Pathology
Principal Investigators
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Guillermo Tearney, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-P000587
Identifier Type: -
Identifier Source: org_study_id
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