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Brief Title: Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Official Title: Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Study ID: NCT02246504
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 decision to retreat the patient will be taken at 1 month post-HIFU or later. Follow-up after HIFU treatment D1 after HIFU session: * Indirect laryngoscopy to check vocal cord mobility. D7 after HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler, M1 after HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler, M3 after HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction. In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed M6 after last HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler * TSH * Free T4 * Antithyroid peroxidase antibodies * Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery) M9 after HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler M12 after last HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler * TSH * Free T4 * Antithyroid peroxidase antibodies * Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery) M18, M24, M36 after HIFU session * Clinical examination (skin, local symptoms, oedema, voice....), * Ultrasonography and Power Doppler
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street, Sofia, , Bulgaria
Name: Roussanka Kovatcheva, Prof.
Affiliation:
Role: PRINCIPAL_INVESTIGATOR