http://clinicaltrials.gov/ct2/show/NCT0 ... SVI&rank=2
Just ran across this, it was linked to at the bottom of the Empire BCBS medical policy change document.
There have been concerns raised that our two safety studies (Dr. Simka and Dr. Siskin's) only dealt with immediate safety, such as what happened during the procedure itself. Still very good that the procedure was very safe in that extreme short term. But the concerns have been what happens in the long term. Thus I am glad to see that in the study details that they have as secondary outcome measures the safety at 3 months, 6 months, 12 months, 18 months and 24 months. ("This is defined as the number and nature of any procedure-related adverse effects.")
Reading the details, I still feel very bad for anyone receiving the sham treatment. Is it patients who have no insurance who would choose to be in such a trial? It's such a long term trial.
When will preliminary data be available? The study began in August of 2010. Completion of the data collection is August 2012 with estimated completion August 2013. I ask because the BCBS policy change document referenced this study and another one and said that no preliminary results were available yet.