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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
HIFU Under ultrasound guidance
University Hospital of Endocrinology USBALE
Sofia, Bulgaria
Number of participants with adverse events
Time frame: 1 day post treatment
Number of participants with adverse events
Time frame: 3 days post treatment
Number of participants with adverse events
Time frame: 7 days post treatment
Change in volume of the thyroid nodule compared to Baseline at 6 months
Time frame: 6 months post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
Time frame: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
Time frame: 3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
Time frame: 7 days post treatment
Patient satisfaction questionnaire
Time frame: 6 months post treatment
Number of patients with Absence of palpable lesion
Time frame: 3 months post treatment
Number of patients with Absence of palpable lesion
Time frame: 6 months post treatment
Patient Cosmetic evaluation measured by questionnaire
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Time frame: 6 months post treatment
Investigator rated evaluation of the device
Time frame: Post treatment Day 0
Change from Baseline of gland vascularization at 3 months
Time frame: 3 months post treatment
Change from Baseline of gland vascularization at 6 months
Time frame: 6 months post treatment