Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:14 - Any
Updated:11/16/2018
Start Date:October 2013
End Date:July 2019
Contact:Guillermo Tearney, MD., PhD
Email:gtearney@partners.org
Phone:617-724-2979

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Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)

The goal of this study is to test the feasibility and the tolerability of a tethered
spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.

72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic
Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked
to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a
tether which allows the operator to control as well as navigate the capsule as it progresses
down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are
acquired. Images are analyzed at a later stage.

Inclusion Criteria:

- Subject must be a healthy volunteer

- OR subject must have a suspicion of EoE

- OR subject must have a prior clinical suspicion of EoE

- Subject must be older than 14 years of age

- Subject must be able to give informed consent

Exclusion Criteria:

- Subjects with the inability to swallow pills and capsules.

- Esophageal fistula and/or esophageal strictures with a stricture diameter that is
smaller than the diameter of the capsule.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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