Barrett's Esophagus Clinical Trial
Official title:
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
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.
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.
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