David, this is a registry, not an experimental study.
Cece I don't like to disagree with you because the last time I did you were right.
I've already forgotten this. (thanks MS memory!) So we're good.
But as I understand it, the registry is a list of medical facilities that will participate in the study. Hubbard's website says:"This is a multi-center registry of CCSVI Testing and Treatment at interventional radiologist facilities all around the country. In this new Registry study, qualified IR may participate if they abide by the protocol that requires objective testing by an outside MRI facility and clinical and MRI evaluations for restenosis or disease progression at 6 and 12 months after treatment. Any treating physician may refer his/her patient with suspected CCSVI, including but not limited to MS. After informed consent is obtained by the participating IR center, the patient is referred to a nearby MRI facility for the Haacke Protocol which will be reviewed by Magnetic Resonance Innovations, Inc. If positive, the IR will perform catheter angiography and if appropriate venoplasty . The patients will be evaluated before and at 6 and 12 months by MRI and disability ratings."
So part of the intent is to provide Liberation treatment at local providers around the country and part of the intent is to show that Liberation either works or not. But I think the later part will require a control group that gets a placebo. Otherwise there is nothing with which to compare the success rate. Possibly they could use the placebo results from the many drug tests done in the past if they aren't proprietary.
OK now shoot me down ... again.
There are different types of trial design. The best possible design is a prospective, placebo-controlled, large-scale, multi-center/multi-practitioner research trial. A registry is not that. But just because it is not the best possible design does not make it without usefulness. It's a fair bit cheaper to run and it's a way to collect the data that is otherwise going to waste, as we get our procedures done clinically.
I did a quick search but didn't come up with the definition of a registry or the list of different types of trials. This popped up, it may help define it somewhat:
http://www.stacommunications.com/journa ... DF/041.pdf