allynz wrote:Not sure if I'm being paranoid but all the navigation is missing off Dr Sclafani's website when it was perfect the other day. We've made a decision to go to him in July but tonight I wanted to complete the registration process but couldn't because everything beyond the home page has disappeared.
The Agency has determined that our Registry is a “clinical study,” that we must submit to them an IDE (investigational device exemption) application, and that all enrollment of subjects must be suspended, although already enrolled subjects should continued to be monitored. Other main points are as follows:
- Each individual device (balloon or stent) must be specified, including manufacturer.
- The procedure and post-procedure (e.g. Use of blood thinners) must be standardized.
- The diseases to be treated (e.g. multiple sclerosis, Parkinsons, Alzheimers, Migraine, Fatigue, Lyme disease) must be standardized.
- The informed consent must be revised to emphasize risk of death (we have not had any).
- In addition, the Agency made suggestions regarding our quality of life measure (SF-36vs) and the definition of “CCSVI.”
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