Treatment of Benign Thyroid Nodules With FastScan HIFU

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT02491502
• Date of registration: 24/06/2015
• Prospective Registration: No
• Primary sponsor: Theraclion
• Public title: Treatment of Benign Thyroid Nodules With FastScan HIFU
• Scientific title: Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
• Date of first enrolment: June 2015
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02491502
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Bulgaria

Contacts

• Name: Roussanka Kovatcheva, Prof.
• Affiliation: [e-mail]

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Benign Thyroid Nodules

Intervention(s)

Device: Echopulse

Primary Outcome(s)

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days [Time Frame: 3 days post treatment]

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days [Time Frame: 7 days post treatment]

Change in volume of the thyroid nodule compared to Baseline at 6 months [Time Frame: 6 months post treatment]

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day [Time Frame: 1 day post treatment]

Number of participants with adverse events [Time Frame: 3 days post treatment]

Patient satisfaction questionnaire [Time Frame: 6 months post treatment]

Number of participants with adverse events [Time Frame: 1 day post treatment]

Number of participants with adverse events [Time Frame: 7 days post treatment]

Secondary Outcome(s)

Change from Baseline of gland vascularization at 6 months [Time Frame: 6 months post treatment]

Change from Baseline of gland vascularization at 3 months [Time Frame: 3 months post treatment]

Investigator rated evaluation of the device [Time Frame: Post treatment Day 0]

Number of patients with Absence of palpable lesion [Time Frame: 3 months post treatment]

Patient Cosmetic evaluation measured by questionnaire [Time Frame: 6 months post treatment]

Number of patients with Absence of palpable lesion [Time Frame: 6 months post treatment]

Secondary ID(s)

HIFU/BG/TN/FS/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors