Treatment of Benign Thyroid Nodules With FastScan HIFU

Not Applicable

Completed

• Conditions: Benign Thyroid Nodules
• Interventions: Device: Echopulse

• Registration Number: NCT02491502
• Lead Sponsor: Theraclion

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Primary Completion: 2020-04
• Study Completion: 2020-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echopulse	Echopulse	Echopulse HIFU

Primary Outcome Measures

Name	Time	Method
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 7 days	7 days post treatment
Patient satisfaction questionnaire	6 months 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 3 days	3 days post treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with Absence of palpable lesion	6 months post treatment
Change from Baseline of gland vascularization at 6 months	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

Trial Locations

Locations (1)

University Hospital of Endocrinology USBALE; 🇧🇬 Sofia, Bulgaria