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

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-16

Study Completion Date

2020-03-18

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.

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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.

Conditions

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Healthy

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 OCT Imaging Capsule

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

Group Type EXPERIMENTAL

MGH OCT Imaging Capsule

Intervention Type DEVICE

Imaging of the esophagus using the OCT Capsule and system.

Interventions

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MGH OCT Imaging Capsule

Imaging of the esophagus using the OCT Capsule and system.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes