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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Theraclion.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01060982
First received: February 1, 2010
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Ultrasonic ablation device
    One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient
    Other Name: TH-One
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060982

Contacts
Contact: Catherine Ortuno catherine.ortuno@theraclion.com

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

No publications provided

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01060982     History of Changes
Other Study ID Numbers: HIFU/F/12.02
Study First Received: February 1, 2010
Last Updated: April 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on April 17, 2014