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Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

NCT07237373 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-29

No results posted yet for this study

Summary

The goal of this observational study is to learn if radiofrequency ablation (RFA), a minimally invasive thermoablation technique, can safely reduce symptoms and improve quality of life in adults with symptomatic benign thyroid nodules or autonomously functioning thyroid nodules.

The main questions it aims to answer are:

* Does RFA improve health-related quality of life (HRQoL) as measured by the ThyPRO-39 questionnaire?
* Does RFA effectively reduce nodule volume and related symptoms (compressive or cosmetic)?

Participants will:

* Undergo a radiofrequency ablation procedure of the thyroid nodule performed under ultrasound guidance in an outpatient setting.
* Complete quality of life questionnaires (ThyPRO-39) before treatment and at follow-up visits.

Attend follow-up visits at 1, 3, 6, and 12 months with:

* Ultrasound assessments of the thyroid nodule
* Symptom and cosmetic scoring
* Blood tests to monitor thyroid function
* Safety checks for possible complications

Conditions

  • Benign Thyroid Nodule

Interventions

DEVICE

Percutaneous radiofrequency ablation

RFA uses an electric field, produced by a radiofrequency generator connected to an internally cooled electrode needle, leading to frictional agitation at the ionic level and to heat generation (Joule effect). The electrode is introduced under US guidance into the target nodule, and a continuous repositioning of the applicator ("moving shot" or "multiple overlapping shot" technique). The localized heating causes necrosis and shrinkage of the thyroid nodule without damaging surrounding tissues. The appearance of hyperechoic signals close to the electrode tip indicates the development of tissue changes and air formation, while a steep rise in tissue impedance demonstrates the achievement of tissue necrosis

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • AZ Sint-Jan AV

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2030-02-28
Completion
2031-04-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237373 on ClinicalTrials.gov