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

Launched by THERACLION · Aug 19, 2011

Keywords

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Gender

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Eligibility criteria

• 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.