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

Mass General Brigham

Status: Active, not recruiting

Conditions: Barrett's Esophagus

Treatments: Device: OFDI Capsule Marking

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02422433

2013-P001254

5R01CA103769-08 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

OFDI Capsule Marking and Imaging

Experimental group

Description:

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.

Treatment:

Device: OFDI Capsule Marking