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

Study Overview
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Brief Summary
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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.

Detailed Description
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60 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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: MGH OCT Imaging Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGH OCT Imaging Capsule<br>Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system. | Device: MGH OCT Imaging Capsule<br>* Imaging of the esophagus using the OCT Capsule and system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. | Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis. | Approximate 20min visit (5min image acquisition) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Care, Healthy