Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation

Conditions
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Barrett's Esophagus

Intervention / Treatment
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* Device: MGH OFDI Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGH OFDI Imaging<br>OFDI imaging | Device: MGH OFDI Imaging<br>* Imaging of Esophagus with OFDI system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions | Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy. | During the OFDI imaging session (about 5 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Barrett's Esophagus, Esophagus, Imaging, Radiofrequency Ablation, BARRX