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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Device: SECM Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc. | An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available. | A single 20 minute visit (5-7 minute imaging). | 
| Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores. | After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort. | Questionnaire adminstered directly after the imaging portion has been completed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SECM, Esophagus, Eosinophilic Esophagitis, Allergy