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CompletedNCT02258347Updated Aug 28, 2019

HIFU in Patients With Non-malignant Thyroid Nodules

An interventional study of Echopulse in Non-malignant Thyroid Nodules, sponsored by Theraclion. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Theraclion · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Non-malignant Thyroid Nodules
03

In context

Lead sponsor

Theraclion is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Single arm

    Device: Echopulse

Interventions

  • DeviceEchopulse
06

What researchers measure

Primary outcomes

  1. Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)

    Time frame: Month 6 and Month 12

  2. Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)

    Time frame: Month 6 and Month 12

  3. Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)

    Time frame: Month 6 and Month 12

Secondary outcomes

  1. Number of subjects with adverse events as a measure of safety and tolerability

    Time frame: Day 1, Month 1, Month 3, Month 6 and Month 12

07

Study locations

1 site
  • Istituto in tecnologie avanzate e modelli assistenziali in oncologia
    Reggio Emilia, 42100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02258347
Lead sponsor
Theraclion
Responsible party
Sponsor
First posted
Oct 7, 2014
Start date
Jul 2014
Primary completion
Oct 13, 2015
Completion
Oct 13, 2015
Last update
Aug 28, 2019

Study contacts

Andrea Frasoldati, Dr
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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