Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study
- 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.
- Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:
- Targeted area located less than 2 mm laterally from the oesophagus or the
- 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.