Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/9/2018
Start Date:August 2014
End Date:January 30, 2018

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The goal of this study is to test the feasibility and acceptability of tethered capsule
Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening
in the primary care practice environment.

20 healthy volunteers scheduled for a routine primary care visit will be recruited and asked
to swallow the OCT 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 through the esophagus, multiple images of the esophagus are
acquired and later analyzed.

Inclusion Criteria:

- Subjects must be scheduled for non-urgent appointment at primary care practice
including annual wellness visits and routine follow-up appointments.

- Subjects must be over the age of 18

- Subjects must be able to give informed consent

- Subjects 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:

- Subjects with current symptoms of dysphagia

- Subjects with any history of intestinal strictures, prior GI surgery, or history of
intestinal Crohn's disease.

- Subjects with current symptoms of fever, nausea or sore throat at the time of the
appointment.

- Pregnancy
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-2368
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Boston, MA
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