Treatment of Benign Thyroid Nodules With FastScan HIFU

Benign Thyroid Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491502
• Other study ID #: HIFU/BG/TN/FS/2015
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2020

Study information

• Verified date: October 2021
• Source: Theraclion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Thyroid Nodules
• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Echopulse
HIFU Under ultrasound guidance

Locations

Country	Name	City	State
Bulgaria	University Hospital of Endocrinology USBALE	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		1 day post treatment
Primary	Number of participants with adverse events		3 days post treatment
Primary	Number of participants with adverse events		7 days post treatment
Primary	Change in volume of the thyroid nodule compared to Baseline at 6 months		6 months post treatment
Primary	Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day		1 day post treatment
Primary	Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days		3 days post treatment
Primary	Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days		7 days post treatment
Primary	Patient satisfaction questionnaire		6 months post treatment
Secondary	Number of patients with Absence of palpable lesion		3 months post treatment
Secondary	Number of patients with Absence of palpable lesion		6 months post treatment
Secondary	Patient Cosmetic evaluation measured by questionnaire		6 months post treatment
Secondary	Investigator rated evaluation of the device		Post treatment Day 0
Secondary	Change from Baseline of gland vascularization at 3 months		3 months post treatment
Secondary	Change from Baseline of gland vascularization at 6 months		6 months post treatment