Treatment of Benign Thyroid Nodules With FastScan HIFU

Study Overview
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Brief Summary
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This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.

Detailed Description
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Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area. In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.

Official Title
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Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)

Conditions
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Benign Thyroid Nodules

Intervention / Treatment
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* Device: Echopulse


Participation Criteria
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Eligibility Criteria
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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: Non suspect clinically and at ultrasonography imaging Benign cytological diagnosis at FNAB (fine-needle aspiration biopsy) from the last 6 months Normal serum calcitonin No history of neck irradiation Normal TSH (thyroid-stimulating hormone) 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) : predominantly solid Patient has signed a written informed consent. 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 the assigned analgesia/anaesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echopulse<br>Echopulse HIFU | Device: Echopulse<br>* HIFU Under ultrasound guidance<br>* Other names: Echopulse HIFU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 1 day post treatment | 
| Number of participants with adverse events |  | 3 days post treatment | 
| Number of participants with adverse events |  | 7 days post treatment | 
| Change in volume of the thyroid nodule compared to Baseline at 6 months |  | 6 months post treatment | 
| Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day |  | 1 day post treatment | 
| Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days |  | 3 days post treatment | 
| Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days |  | 7 days post treatment | 
| Patient satisfaction questionnaire |  | 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Absence of palpable lesion |  | 3 months post treatment | 
| Number of patients with Absence of palpable lesion |  | 6 months post treatment | 
| Patient Cosmetic evaluation measured by questionnaire |  | 6 months post treatment | 
| Investigator rated evaluation of the device |  | Post treatment Day 0 | 
| Change from Baseline of gland vascularization at 3 months |  | 3 months post treatment | 
| Change from Baseline of gland vascularization at 6 months |  | 6 months post treatment |