BCSailor wrote:could someone please point me to what dr sclafani's proposed study was?
Was this ever posted anywhere?
drsclafani wrote:my study is a safety study and calls for ME to do each study. I will have assistants but i will be the primary operator of each case. After 200 cases, we should be able to triple the rate of procedures. I would like to perform 10 per week, but need additional neurologists to do intake to get to that level.
we are going to do an open label safety study, not a randomized prospective blinded treatment trial. A randomized trial will require funding and a multicenter organization that is not in place now.
drsclafani wrote:we could study this. but First safety. no one has corroberated zamboni yet. We hear lots of anecdotes about recurrents after encouraging early outcomes. We need to clarify this before we can compare drug therapies.
why argue with it. by proving safety we clarify techniques safety and complications and patients get treated.
we are not ready for randomization.
lets get several 200-300 patient studies completed and we will have learned a lot. that will allow many patients to be treated while proving safety and efficacy.
then we can move toward stent versus no stent, venoplasty plus ms therapy vs venoplasty without drug therapy, etc. you get my idea. in the mean time we can treat a couple of thousand patients while we assure to the medical community that no one has been treated dangerously
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