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

May 5, 2014 updated by: Theraclion

Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75014
        • Cochin Hospital
      • Paris, France, 75013
        • Hôpital Privé des Peupliers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIFU treatment
One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient
Other Names:
  • TH-One

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histology of excised gland.
Time Frame: After surgery performed the same day as High intensity focused ultrasound treatment
After surgery performed the same day as High intensity focused ultrasound treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Philippe BONNICHON, MD, Cochin Hospital, Paris, Fance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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