Sarasota Memorial’s thyroid/parathyroid specialist Ralph P. Tufano, MD, MBA, FACS, in conjunction with SMH’s Kolschowsky Research and Education Institute, are leading a multicenter study to capture the clinical and quality of life benefits of a new ablation treatment for non-cancerous thyroid nodules.
In the PRECISE-BTN study, principal investigator Dr. Tufano and other thyroid specialists are using Pulse Biosciences’ Nanosecond Pulsed Field Ablation (nsPFA) technology to treat patients with benign thyroid nodules (BTNs). The novel percutaneous electrode system was cleared by the Food & Drug Administration in 2024 for ablation of soft tissue. While previous studies have
demonstrated the procedure is safe, physicians participating in the research study believe the strong results they have observed in the past year support adding it to the current standards of care. Currently, the treatment is commercially available to self-pay and insured patients, but some insurances do not always cover the cost.“The objective of this multicenter clinical study is to continue to build clinical evidence in support of this patient-friendly procedure by showing we can safely reduce the debilitating symptoms caused by BTNs while preserving thyroid function and avoiding complete thyroid removal,” said Dr. Tufano, director Head and Neck Endocrine Surgery at Sarasota Memorial and SMH/FPG Thyroid and Parathyroid Center and physician leader with SMH’s Brian D. Jellison Cancer Institute.
Dr. Tufano worked with Pulse Biosciences to help develop the application for which nanosecond pulse frequency energy is delivered to a thyroid nodule, and successfully performed more than 50 nsPFA procedures prior to launching this study. In August, he treated the first patients enrolled in the study. “The procedures were successful, and we are showing early positive results. We look forward to providing further updates as patients progress,” he said.
In the coming months, three other research centers also will join the study, enrolling up to 50 patients. All will be treated with Pulse Bioscience’s nsPFA Percutaneous Electrode System and followed for a year to assess clinical and quality-of-life indicators, including reductions in the volume/size of targeted nodules, symptom relief, and improvements in appearance and quality of life.
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences, is looking forward to documenting the results.
“In addition to the remarkable work done to enroll and treat our first patients in the PRECISE-BTN multicenter clinical study, we continue to successfully treat patients through the pilot phase of our commercial launch,” LaViolette said. “The progression of our clinical studies highlights our commitment to advancing patient treatment and providing valuable insights and outcomes in our field.”