Treatment of Benign Thyroid Nodules With FastScan HIFU

NCT ID: NCT02491502

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2020-07-31

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.

Conditions

Benign Thyroid Nodules

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Echopulse

Echopulse HIFU

Group Type: EXPERIMENTAL

Echopulse

Intervention Type: DEVICE

HIFU Under ultrasound guidance

Interventions

Echopulse

HIFU Under ultrasound guidance

Intervention Type: DEVICE

Other Intervention Names

Echopulse HIFU

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theraclion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roussanka Kovatcheva, Prof.

Role: PRINCIPAL_INVESTIGATOR

roussanka_kov@yahoo.com

Locations

University Hospital of Endocrinology USBALE

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

HIFU/BG/TN/FS/2015

Identifier Type: -

Identifier Source: org_study_id