Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation (OFDI)
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|ClinicalTrials.gov Identifier: NCT01439594|
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Esophagus||Device: MGH OFDI Imaging||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: MGH OFDI Imaging
Device: MGH OFDI Imaging
Imaging of Esophagus with OFDI system
- 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 ]Images will be analyzed and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|