Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

Inclusion Criteria:

• Male or female patients 18 years or older with end stage renal disease (ESRD) on thrice-weekly stable haemodialysis since at least 3 months with biochemically uncontrolled secondary hyperparathyroidism.
• PTH > 800 pg/ml with serum calcium > 8.4 mg/dl shown by three measurements obtained within a 30-day screening period, in spite of established maintenance dose for at least 3 months of Cinacalcet (>30mg/day) with or without vitamin D .
• Patients who underwent subtotal parathyroidectomy or total parathyroidectomy without autotransplantation and have recurrent secondary hyperparathyroidism, are eligible provided that they meet all the other inclusion criteria and exclusion criteria.
• Patients with one or two enlarged parathyroid glands, located with ultrasonography and with one or two over-active glands at sestamibi scintigraphy.

Exclusion Criteria:

• Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
• Serum total calcium (corrected for albumin) < 8.4 mg/dl (2.1 mmol/l)
• Serum ionized calcium < 1 mmo/l.
• Patient who underwent total parathyroidectomy with autotransplantation.
• Known history of parathyroid or other neoplasias in the neck region.
• History of neck irradiation
• Patients with abnormal vocal cord mobility revealed by indirect laryngoscopy
• Patients with enlarged parathyroid glands, not accessible to HIFU treatment.
• Head and/or neck disease that prevents hyperextension of neck. - Major surgery or arterio-venous fistula clotting in the last 3 months or major surgery projected in the subsequent 4 months.
• Pregnant or lactating woman.
• Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
• Patient receiving drugs such as flecainide, thioridazine, and most tricyclic antidepressants.
• Patients who are currently participating in another clinical trial.