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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-03-31

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).

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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.

Conditions

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Healthy Barrett's Esophagus Gastric Acid Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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MGH SECM Imaging Capsule

Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.

Group Type EXPERIMENTAL

MGH SECM Imaging Capsule

Intervention Type DEVICE

Imaging of the Esophagus using the SECM capsule and SECM Imaging system

Interventions

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MGH SECM Imaging Capsule

Imaging of the Esophagus using the SECM capsule and SECM Imaging system

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes