Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation (OFDI)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation|
- Feasibility and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ] [ Designated as safety issue: No ]Images will be analyzed and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques
|Study Start Date:||October 2008|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: MGH OFDI Imaging
Device: MGH OFDI Imaging
Imaging of Esophagus with OFDI system
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439594
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Guillermo Tearney, MD PhD||Massachusetts General Hospital|
|Principal Investigator:||Norman Nishioka, MD||Massachusetts General Hospital|