HIFU in Patients With Non-malignant Thyroid Nodules

Theraclion

Status: Completed

Conditions: Non-malignant Thyroid Nodules

Treatments: Device: Echopulse

Study type: Interventional

Funder types: Industry

Identifiers

NCT02258347

HIFU/REG/NT

Details and patient eligibility

About

Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 fine-needle aspiration biopsy (FNAB) from the last 6 months
  3. Normal serum calcitonin
  4. No history of neck irradiation

• Normal thyroid-stimulating hormone (TSH).

• Targeted nodule accessible and eligible to HIFU

• Absence of abnormal vocal cord mobility at laryngoscopy.

• Nodule diameter ≥ 10mm measured by ultrasound.

• Nodule volume inferior to 10 cc

• Composition of the targeted nodule(s) : no more than 30% cystic

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Single arm

Experimental group

Treatment:

Device: Echopulse