Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

Mass General Brigham

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: MGH OFDI Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01439594

2008-P000793

Details and patient eligibility

About

The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

Full description

This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.

Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.

Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of Barrett's esophagus
• Patients undergoing an Esophagogastroduodenoscopy (EGD)
• Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
• Patients must be over the age of 18
• Patient must be able to give informed consent
• Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion criteria

• Patients on oral anticoagulation medications
• Patients with a history of hemostasis disorders
• Patients that are pregnant
• Patients with esophageal strictures

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

MGH OFDI Imaging

Experimental group

Description:

OFDI imaging

Treatment:

Device: MGH OFDI Imaging