Treatment of Benign Thyroid Nodules With FastScan HIFU

Theraclion

Status: Completed

Conditions: Benign Thyroid Nodules

Treatments: Device: Echopulse

Study type: Interventional

Funder types: Industry

Identifiers

NCT02491502

HIFU/BG/TN/FS/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Echopulse

Experimental group

Description:

Echopulse HIFU

Treatment:

Device: Echopulse