Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules (BIRRO-TA)

April 23, 2026 updated by: University Hospital, Ghent

Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules: a Prospective Multicentric Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Benign thyroid nodules are highly prevalent in the adult population. While most remain asymptomatic, some patients experience compressive symptoms, cosmetic concerns, or hyperthyroidism due to autonomously functioning nodules. Standard therapy is hemithyroidectomy or total thyroidectomy, which is effective but associated with risks such as hypothyroidism, nerve injury, visible scarring, and increased health care costs. As a result, minimally invasive, nonsurgical alternatives are being actively investigated.

Radiofrequency ablation (RFA) is a percutaneous thermoablation technique performed under ultrasound guidance using a cooled electrode needle. Heat generated at the electrode tip induces localized necrosis within the target nodule, leading to progressive shrinkage while sparing surrounding thyroid tissue. In most cases, the procedure is carried out under local anesthesia in an outpatient setting, with an average duration of 15-40 minutes. The "moving shot" technique is typically employed, allowing precise ablation of large nodules in multiple overlapping steps.

International guidelines from the European Thyroid Association (ETA) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recommend RFA as an alternative for patients with benign thyroid nodules who present with compressive symptoms, cosmetic complaints, or autonomously functioning thyroid nodules not suitable for surgery or radioactive iodine.

This multicenter prospective observational study will investigate the clinical effectiveness and safety of RFA in routine practice. The primary outcome is health-related quality of life (HRQoL), assessed by the validated ThyPRO-39 instrument. Secondary outcomes include technical efficacy (≥50% volume reduction rate), symptom and cosmetic improvement, stability of thyroid function, and safety endpoints based on the CIRSE classification of complications.

Participants will undergo standardized baseline evaluation including ultrasound, cytology, and thyroid function testing. Follow-up visits are scheduled at 1, 3, 6, and 12 months, with systematic assessments of nodule characteristics, laboratory values, patient-reported outcomes, and complications. Technical success and regrowth will be defined according to internationally accepted thresholds.

By collecting prospective multicenter data, this study aims to generate high-quality evidence on the role of RFA in the treatment of benign thyroid nodules. The results are expected to strengthen the scientific and economic case for adopting RFA as a reimbursable, minimally invasive therapy in clinical practice, while contributing to the long-term body of literature on patient-centered outcomes in thyroid disease.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bruges, Belgium, 8000
        • Not yet recruiting
        • AZ Sint-Jan Brugge
        • Contact:
        • Principal Investigator:
          • Andries Van Holsbeeck, MD
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
        • Principal Investigator:
          • Charlotte Harth, MD
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • Geert Maleux, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants will be selected from the following Belgian hospitals: Ghent University Hospital, University Hospital Leuven, AZ Sint Jan Brugge.

Description

Inclusion Criteria:

  • > 18 years old
  • 'Eastern Cooperative Oncology Group' (ECOG) performance status of 0 or 1
  • Symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.
  • No cutoff in nodule size.
  • Solid component > 20%, and benign cytology (Bethesda II) in 1 (EUTIRADS 3) or 2 (EUTIRADS 4) separate cytological assessments. In the case of a proven "hot" nodule on scintigraphy, no biopsy is required.

Exclusion Criteria:

  • <18y
  • Purely cystic nodule
  • Severe comorbidity which limits the further life expectancy of the patient to < 2 years (opinion of the physician)
  • Malignancies <2 years ago except for non-melanoma skin cancer and non-muscle invasive bladder cancer.
  • Lack of compliance
  • Malignant or suspicious thyroid nodules or nodules that are confluent in a compressive lobar mass
  • Contralateral vocal cord paralysis
  • Anticoagulant therapy that could not be suspended
  • Unresolvable coagulation disorders
  • Absence of consent of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign thyriod nodules
Subjects with symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.
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
Other Names:
  • RFA
  • radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality Of Life (HRQoL)
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months
HRQoL will be assessed by the change in Thyroid-Related Patient-Reported Outcome 39 (ThyPRO-39) score from baseline to 1-year follow-up. The ThyPRO-39 is a thyroid-specific quality of life instrument covering 13 domains of QoL validated for patients with benign thyroid disease. The ThyPRO-39 includes scales assessing the following: goiter symptoms, eye symptoms, hyperthyroid symptoms, hypothyroid symptoms, tiredness, cognitive complaints, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, appearance, and overall QoL. Each item is rated on a Likert scale (0-4) from 0 = "no symptoms/problems" to 4 = "severe symptoms/problems." Scores are then transformed to yield 13 0-100 scales, where a higher score indicates worse health-related QoL
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom score
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Registered on a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "no symptoms" and 10 indicates "worst imaginable symptoms".
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Cosmetic score
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Assessed during physical examination; ranging from 1 to 4, where 1 graded as no palpable mass, 2 graded as a palpable mass without cosmetic issue, 3 graded as a cosmetic problem on swallowing, and 4 as a readily detected cosmetic problem.
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Number of Participants with Treatment-Related Adverse Events
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Safety will be measured based on the presence of minor or major complications. Major and minor complications are those defined by the Society of Interventional Radiology.
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Volume Reduction Rate (VRR)
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Calculated as VRR (%) = (initial volume - final volume) ÷ initial volume × 100
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Technical efficacy
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Defined as a VRR ≥50%. Regrowth is defined as an increase in nodule volume to at least 150% of the minimum recorded volume during the follow-up period.
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Thyroid function
Time Frame: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.
Evaluation of thyroid function, including serum TSH, free T4 (FT4), and free T3 (FT3) levels
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Universitaire Ziekenhuizen KU Leuven
AZ Sint-Jan AV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2026

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2025-0427

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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