Status:
COMPLETED
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Lead Sponsor:
Theraclion
Conditions:
Non-malignant Thyroid Nodule
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography
Detailed Description
HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist. A maximum of 2 HIFU sessions per nodule will be performed per patient. The decisi...
Eligibility Criteria
Inclusion
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Non suspect clinically and at ultrasonography imaging
- Benign cytological diagnosis at FNAB from the last 6 months
- Normal serum calcitonin
- No history of neck irradiation
- Normal TSH.
- Targeted nodule accessible and eligible to HIFU
- Absence of abnormal vocal cord mobility at laryngoscopy.
- Nodule diameter ≥ 10mm measured by ultrasound.
- Composition of the targeted nodule(s) : no more than 30% cystic
Exclusion
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of thyroid cancer or other neoplasias in the neck region.
- History of neck irradiation.
- Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
- Posterior position of the nodule if the thickness of the nodule is \<15mm
- Pregnant or lactating woman
- Any contraindication to IV neurolept analgesia.
Key Trial Info
Start Date :
October 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02246504
Start Date
October 9 2012
End Date
March 7 2017
Last Update
September 17 2019
Active Locations (1)
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1
Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street
Sofia, Bulgaria, 14031