Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | October 2008 |
| End Date: | March 2014 |
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.
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.
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.
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
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