New Ethics Board Study Application for Enhanced CCSVI Treatment Protocol Focuses on Long-term Success
Posted Dec 21 2010 7:13pm
CCSVI Clinic Physicians ( www.ccsviclinic.ca ) have applied for an International ethics board study approval that will allow them to use the data on patients where their new treatment protocol is being studied. Dr. Anand Alurkar, the Interventional Neurosurgeon at Noble Hospital has done thousands of Intra and Extra cranial angio-procedures over the past 10 years. His studies indicate that it’s critical to position and movement control patients who have had venous angioplasty post-procedure, monitor them for days afterward with various imaging techniques, for other symptoms, and re-treat if necessary. CCSVI Clinic is already sponsoring patients for this protocol with a 10-day stay in the hospital where patients will be imaged daily, post procedure. If there is evidence of re-occlusion, they will be taken back to the OR and re-treated. Dr. Alurkar’s past studies of non-MS patients with the same venous blockages have noted a cascade of failure points distally in venous vessels post angioplasty, and he would expect that the study with MS patients will produce the same results. His normal treatment regime includes a protocol which includes a high concentration on post-procedure aftercare and follow-up. To comply with the ethics board approval, once home, patients will be examined and interviewed at regular intervals by CCSVI Clinic Physician Researchers for several years after the treatment to study the changes.
More and more MS patients are reporting initial success (including vascular and some neurological differences) as a result of the venous angioplasty (liberation therapy) but then regression to previous symptoms sometimes within weeks post-procedure. It is estimated that the failure rate of the “liberation therapy” may be 50% or higher, even through the most experienced and best-known surgeons in Poland and Albany, NY. Consequently, there is increasing concern amongst patients that the procedure hypothesis needs to include a post-procedure protocol that is more effective than simply releasing the patient from the hospital or clinic within hours or a day of the procedure. Dr. Alurkar’s previous studies reveal there are many other considerations that indicate a stabilization period, re-examination, and re-treatment if necessary. Where protocol is followed, the current results have been consistently high enough to confirm Alurkar’s hypothesis.
Furthermore, it’s the universal feeling of the physicians and researchers at Noble Hospital, who are in a research partnership with CCSVI Clinic, (with offices and research associates in Winnipeg, Toronto and Atlanta) that many corners are being cut by all big clinics performing the procedure to take advantage of the over-whelming world-wide demand for treatment in an opportunistic approach that focuses on hospital revenue. It is also possible that these physicians, besides being drawn to the financial benefits of the procedure, are unaware of the post-procedure hypothesis put forward by Dr. Alurkar for his non-MS patient population studies.
Noble Hospital and CCSVI Clinic are expecting ethics board approval for their study within 30 days and results will be released on an ongoing basis given the already high interest in the findings. The goal with this study is to provide a prospective look at patients undergoing the “liberation therapy” with the extended post-procedure protocol and compare it to patients who receive minimal post-procedure surveillance.
Regular research updates will be published on the CCSVI Clinic website. Questions may be directed toward the CCSVI Clinic administration at 1-888-419-6855. Persons wishing to book a procedure should call the same number but should recognize that they must participate in the study and will be followed for several years by the study research team. Interested persons should ensure that applications are in as soon as possible since there are limitations on the study population.