RecruitingNot ApplicableNCT02947971
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Sponsor
Massachusetts General Hospital
Enrollment
120 participants
Start Date
Apr 15, 2016
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
Eligibility
Min Age: 14 YearsMax Age: 85 Years
Inclusion Criteria4
- Participants 18 years and older with a previous diagnosis of GERD
- 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 Criteria5
- Participants over 85 years of age
- 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.
Interventions
DEVICEExperimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02947971
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