Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule

Study Overview
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Brief Summary
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The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).

Detailed Description
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36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated. 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 natural propulsive force called peristalsis. As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Official Title
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Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule

Conditions
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Healthy, Barrett's Esophagus, Gastric Acid Reflux

Intervention / Treatment
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* Device: MGH SECM Imaging Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older). AND Subject must be able to give informed consent. AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure. Exclusion Criteria: Subjects with any history of or known upper gastrointestinal strictures OR Subjects with a history of Crohn's disease, OR Subjects with difficulty swallow

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 SECM Imaging Capsule<br>Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. | Device: MGH SECM Imaging Capsule<br>* Imaging of the Esophagus using the SECM capsule and SECM Imaging system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. | The number of subjects from whom successful SECM imaging was obtained | 20 minute visit (5-7 minute imaging) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's, GERD, Capsule, SECM