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I am not sure what the difference is between a registry and a clinical study, or if the FDA is correct that the registry is a clinical study. I think it is good to specify the manufacturers of devices used. It makes sense for the procedure to be standardized if this is a study, so that the data from the first patient and the data from the last patient were obtained in the same way after the same procedure, but I am not convinced that this needs to be the case if it is a registry? And the diseases to be treated must be standardized! The disease being treated is central venous stenosis. There may be co-existing diseases including but not limited to those listed. But it takes us down the wrong path to say that the disease being treated is anything other than central venous stenosis. It may be a previously unidentified form of central venous stenosis -- congenital intraluminal abnormalities of the main cerebrospinal drainage veins -- but it is central venous stenosis.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.”