Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure
This study is currently recruiting participants.
Verified April 2012 by Theraclion
Sponsor:
Theraclion
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01060982
First received: February 1, 2010
Last updated: April 5, 2012
Last verified: April 2012
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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:
Genetics Home Reference related topics:
familial isolated hyperparathyroidism
hyperparathyroidism-jaw tumor syndrome
Drug Information available for:
Parathyroid
U.S. FDA Resources
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
![](https://webarchive.library.unt.edu/web/20121019005729im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
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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 |
![](https://webarchive.library.unt.edu/web/20121019005729im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 October 17, 2012