Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure

Inclusion Criteria:

• Male or female patient 18 years or older.
• Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
• One diseased parathyroid gland, visualized by ultrasonography.
• The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
• Normal pretreatment nasofibroscopy.
• Voluntary signed informed consent.

Exclusion Criteria:

• Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:

  • Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
  • Targeted area located less than 3 mm laterally from the trachea,
  • Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
• Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
• Known spondylitis of the neck vertebrae
• Head and/or neck disease that prevents hyperextension of neck.
• Known history of parathyroid or other neoplasias in the neck region.
• History of neck irradiation
• Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
• Pregnant or lactating woman.
• Female patient of childbearing age if not having a suitable contraception method.
• Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial.