Treatment of Benign Thyroid Nodules With FastScan HIFU

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02491502

Enrollment

Registered

2015-07-08

Start date

2015-06-30

Completion date

2020-07-31

Last updated

2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Thyroid Nodules

Brief summary

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

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.

Interventions

DEVICEEchopulse

HIFU Under ultrasound guidance

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 (fine-needle aspiration biopsy) from the last 6 months 3. Normal serum calcitonin 4. 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.

Design outcomes

Primary

Measure	Time frame
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
Number of participants with adverse events	1 day post treatment
Change in volume of the thyroid nodule compared to Baseline at 6 months	6 months post treatment

Secondary

Measure	Time frame
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
Number of patients with Absence of palpable lesion	3 months post treatment

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026