Non-malignant Thyroid Nodule Clinical Trial
Official title:
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Verified date | September 2019 |
Source | Theraclion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography
Status | Completed |
Enrollment | 20 |
Est. completion date | March 7, 2017 |
Est. primary completion date | March 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patient 18 years or older. - Patient presenting with at least one thyroid nodule with no signs of malignancy: 1. Non suspect clinically and at ultrasonography imaging 2. Benign cytological diagnosis at FNAB from the last 6 months 3. Normal serum calcitonin 4. 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street | Sofia |
Lead Sponsor | Collaborator |
---|---|
Theraclion |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in thyroid nodule's volume | Month 6 | ||
Secondary | Change from baseline in thyroid nodule's structure and vascularisation | Month 6 | ||
Secondary | Number of participants with adverse events | D1, D7, M1, M3 and M6 |