Treatment of Benign Thyroid Nodules With FastScan HIFU

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Thyroid Nodules
• Intervention / Treatment: Device: Echopulse

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1431
    • University Hospital of Endocrinology USBALE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echopulse; Echopulse HIFU	Device: Echopulse; HIFU Under ultrasound guidance; Other Names: Echopulse HIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Theraclion
• Investigators: Principal Investigator: Roussanka Kovatcheva, Prof., roussanka_kov@yahoo.com

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: HIFU/BG/TN/FS/2015