Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental OFDI Imaging.
- Who it may be relevant to
- Registry conditions: Barrett's Esophagus. Basic parameters: 14 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Overview
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.
Detailed description
Ten healthy participants and ten participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.
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.
Interventions
- Device Experimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter
Primary outcome measures
- Assessment of quality and performance of Compact Imaging System (CIS) [Time frame: 5-7 Minutes of imaging]
Eligibility criteria
Inclusion criteria
- A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
- Participants 18 years and older with a previous diagnosis of GERD
- Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers)
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General hospital — Boston
Identifiers
NCT: NCT02947971 · 2015-P000587 · 5R01CA184102-02