Status:
WITHDRAWN
Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism
Lead Sponsor:
Theraclion
Conditions:
Secondary Hyperparathyroidism
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term haemodialysis treatment. sHPT is characterized by persistentl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01421407
Start Date
August 1 2011
End Date
January 1 2014
Last Update
May 6 2014
Active Locations (3)
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1
Ospedale generale regionale "Miulli"
Acquaviva delle Fonti, Italy, 70021
2
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, Italy, 20122
3
Hospital Universitario Marquès de Valdecilla
Santander, Cantabria, Spain, 39008