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Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echopulse | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 | |
| Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 | |
| Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US) | Month 6 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | Day 1, Month 1, Month 3, Month 6 and Month 12 |
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Inclusion Criteria:
Male or female patient 18 years or older.
Patient presenting with at least one thyroid nodule with no signs of malignancy:
Normal thyroid-stimulating hormone (TSH).
Targeted nodule accessible and eligible to HIFU
Absence of abnormal vocal cord mobility at laryngoscopy.
Nodule diameter ≥ 10mm measured by ultrasound.
Nodule volume inferior to 10 cc
Composition of the targeted nodule(s) : no more than 30% cystic
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Frasoldati, Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto in tecnologie avanzate e modelli assistenziali in oncologia | Reggio Emilia | 42100 | Italy |
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