Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2029-12-31

Brief Summary

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The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

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Detailed Description

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A total of 130 participants scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.

Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Conditions

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Barrett's Esophagus

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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OFDI Capsule Marking and Imaging

Participant will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.

Group Type EXPERIMENTAL

OFDI Capsule Marking

Intervention Type DEVICE

Marking and imaging of the esophagus using the OFDI Capsule and system.

Interventions

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OFDI Capsule Marking

Marking and imaging of the esophagus using the OFDI Capsule and system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients must be undergoing an EGD.
* Patients must be over the age of 18.
* Patients must be able to give informed consent.

Exclusion Criteria

* Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
* OR patients with a history of hemostasis disorders.
* OR patients with esophageal strictures.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No