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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 2, 2010
Last Update Posted: May 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.

Condition Intervention
Primary Parathyroid Adenomas Device: Ultrasonic ablation device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study

Resource links provided by NLM:

Further study details as provided by Theraclion:

Primary Outcome Measures:
  • Histology of excised gland. [ Time Frame: After surgery performed the same day as High intensity focused ultrasound treatment ]

Enrollment: 5
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIFU treatment Device: Ultrasonic ablation device
One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient
Other Name: TH-One


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060982

Hôpital Privé des Peupliers
Paris, France, 75013
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Principal Investigator: Philippe BONNICHON, MD Cochin Hospital, Paris, Fance
  More Information

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01060982     History of Changes
Other Study ID Numbers: HIFU/F/12.02
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Theraclion:
Primary hyperparathyroidism
High Intensity Focused Ultrasound
Parathyroid tumor
Parathyroid hormone

Additional relevant MeSH terms:
Parathyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Parathyroid Diseases