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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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96 participants including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a current or prior 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.

Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Imaging

Participant will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.

Group Type EXPERIMENTAL

SECM Capsule

Intervention Type DEVICE

Imaging of the esophagus using the SECM capsule and system

Interventions

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SECM Capsule

Imaging of the esophagus using the SECM capsule and system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participant must be a healthy volunteer
* OR participant must have a suspicion of EoE
* OR participant must have a prior clinical suspicion of EoE
* Participant must be older than 14 years of age
* Participant must be able to give informed consent

Exclusion Criteria

* Participants 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.
* Participants with prior endoscopic ablation or resection treatment of Barrett's Esophagus (BE)

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes