FDA Notified About a Clinic Prematurely Doing Thyroid RFA in the USA Without a Clinical Trial.
Respected AACE member ( not me ) notified the FDA today.
“It has come to my attention that a facility in Utah ( ?Utah Clinic) is doing thyroid nodule RFA (ablation) without a US clinical trial. ……… Please keep my notification anonymous and please respond to me re: my notification. Endocrinology has not been performing this procedure with no clinical trials performed in USA.”
The clinic mentioned has purchased the generator and probes from the Korean company and has begun treating patients and advertising to recruit new patients off their website (www.thyroidablation.com).
According to my sources they have no planned clinical trial and are just treating patients. The website offers sign up for possible patient candidates. They just took a 3 day course in Korea and quickly bought a system from the US distributor and began doing Thyroid RFA within weeks of returning from Korea. My source at the U. of Utah says they know the 2 physicians but did not know of their present use in treating patients with Thyroid RFA. This is in my opinion a potential risk for those patients who decide to have the procedure with inexperienced operators.
American Association of Clinical Endocrinologists AACE’s task force on thyroid ablation recommended the education committee should begin evaluating the best way to train members and to foster the production of the first clinical trial.
Until then I am recommending my patients to avoid the Utah clinic and go to Italy or Korea for thyroid RFA with expert operators. If they can not go then ATA guideline is surgery as the treatment of choice for benign symptomatic nodules in the USA.
I have been teaching thyroid RFA ablation techniques in my center for 7 months to interested endocrinologists to prepare them for future certification courses given by AACE. I have never used my generator to treat a human and only use models for my students to practice. I never intended any to buy a generator and begin treating without formal training and production of a clinical trial.
Endocrinologist doing RFA on a bovine liver model with “beef”nodules.
Call me at 310-393-8860 or email to email@example.com for details of the desire to travel for alternative therapy to surgery.