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Benign Thyroid NoduleBIRRO-TANCT07237373

Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

An observational study of Benign Thyroid Nodule, run by University Hospital, Ghent at 3 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Benign Thyroid Nodule
What is being tested?
Percutaneous radiofrequency ablation
Type of treatment
Medical device
How many people
100 participants
Where
3 sitesBelgium
Study dates
3 Mar 2026to 1 Apr 2031
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • > 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.

Who cannot join

  • <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
Show all 10Show fewer
  • Contralateral vocal cord paralysis
  • Anticoagulant therapy that could not be suspended
  • Unresolvable coagulation disorders
  • Absence of consent of the patient

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Charlotte Harth, MD contact

+32 9 332 0450

studies.vinrad@uzgent.be

Lien Van Cauwenberghe, MSc contact

+32 9 332 0450

lien.vancauwenberghe@uzgent.be

Belgium3 sites, 3 recruiting

  • AZ Sint-Jan Brugge

    Bruges, 8000

    Andries Van Holsbeeck, MD, +32 50 45 21 01, rx.afspraken@azsintjan.be

    Andries Van Holsbeeck, MD

    Recruiting

  • UZ Gent

    Ghent, 9000

    Charlotte Harth, MD, +32 9 332 0450, charlotte.harth@uzgent.be

    Charlotte Harth, MD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Geert Maleux, +32 16 34 36 60, radiologie@uzleuven.be

    Geert Maleux, PhD

    Recruiting

Other trials in Belgium

About this study

Official title: 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:

Read more
  • 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
Read the 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.

Being tested
Percutaneous radiofrequency ablation
Keywords
benign thyroid nodule, radiofrequency ablation, interventional radiology, percutaneous thermoablation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous radiofrequency ablationDevice

    Also called RFA, 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

Study groups in NCT07237373
Study groupRoleWhat they receive
Benign thyriod nodulesSubjects with symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.
Receives: Device: Percutaneous radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related Quality Of Life (HRQoL)

    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

    Measured: 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 outcomes (6)

  1. Symptom score

    Registered on a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "no symptoms" and 10 indicates "worst imaginable symptoms".

    Measured: 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.

  2. Cosmetic score

    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.

    Measured: 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.

  3. Number of Participants with Treatment-Related Adverse Events

    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.

    Measured: 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.

  4. Volume Reduction Rate (VRR)

    Calculated as VRR (%) = (initial volume - final volume) ÷ initial volume × 100

    Measured: 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.

  5. Technical efficacy

    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.

    Measured: 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.

  6. Thyroid function

    Evaluation of thyroid function, including serum TSH, free T4 (FT4), and free T3 (FT3) levels

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start3 Mar 2026
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion1 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237373
Sponsor's protocol ID
ONZ-2025-0427
Acronym
BIRRO-TA
Status last verified
Aug 2026
First submitted
14 Nov 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shein-Chung Chow JS, Hansheng Wang, Yuliya Lokhnygina. Sample Size Calculations in Clinical Research. 3rd Edition ed2017.

  • Nordqvist SF, Boesen VB, Rasmussen AK, Feldt-Rasmussen U, Hegedus L, Bonnema SJ, Cramon PK, Watt T, Groenvold M, Bjorner JB. Determining minimal important change for the thyroid-related quality of life questionnaire ThyPRO. Endocr Connect. 2021 Mar;10(3):316-324. doi: 10.1530/EC-21-0026.

    PubMed 33617467

  • Uslar V, Becker C, Weyhe D, Tabriz N. Thyroid disease-specific quality of life questionnaires - A systematic review. Endocrinol Diabetes Metab. 2022 Sep;5(5):e357. doi: 10.1002/edm2.357. Epub 2022 Jul 20.

    PubMed 35856310

  • Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26.

    PubMed 26214034

  • Reuters KB, Mamone MCOC, Ikejiri ES, Camacho CP, Nakabashi CCD, Janovsky CCPS, Yang JH, Andreoni DM, Padovani R, Maciel RMB, Vanderlei FAB, Biscolla RPM. Bethesda Classification and Cytohistological Correlation of Thyroid Nodules in a Brazilian Thyroid Disease Center. Eur Thyroid J. 2018 Jun;7(3):133-138. doi: 10.1159/000488104. Epub 2018 Apr 27.

    PubMed 30023345

  • Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5.

    PubMed 28584945

  • Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8.

    PubMed 29167761

  • Wang JF, Wu T, Hu KP, Xu W, Zheng BW, Tong G, Yao ZC, Liu B, Ren J. Complications Following Radiofrequency Ablation of Benign Thyroid Nodules: A Systematic Review. Chin Med J (Engl). 2017 Jun 5;130(11):1361-1370. doi: 10.4103/0366-6999.206347.

    PubMed 28524837

  • Hegedus L, Frasoldati A, Negro R, Papini E. European Thyroid Association Survey on Use of Minimally Invasive Techniques for Thyroid Nodules. Eur Thyroid J. 2020 Jul;9(4):194-204. doi: 10.1159/000506513. Epub 2020 Mar 27.

    PubMed 32903971

  • Bernardi S, Dobrinja C, Fabris B, Bazzocchi G, Sabato N, Ulcigrai V, Giacca M, Barro E, De Manzini N, Stacul F. Radiofrequency ablation compared to surgery for the treatment of benign thyroid nodules. Int J Endocrinol. 2014;2014:934595. doi: 10.1155/2014/934595. Epub 2014 Jun 22.

    PubMed 25045352

  • Deandrea M, Trimboli P, Garino F, Mormile A, Magliona G, Ramunni MJ, Giovanella L, Limone PP. Long-Term Efficacy of a Single Session of RFA for Benign Thyroid Nodules: A Longitudinal 5-Year Observational Study. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3751-3756. doi: 10.1210/jc.2018-02808.

    PubMed 30860579

  • Baek JH, Lee JH, Sung JY, Bae JI, Kim KT, Sim J, Baek SM, Kim YS, Shin JH, Park JS, Kim DW, Kim JH, Kim EK, Jung SL, Na DG; Korean Society of Thyroid Radiology. Complications encountered in the treatment of benign thyroid nodules with US-guided radiofrequency ablation: a multicenter study. Radiology. 2012 Jan;262(1):335-42. doi: 10.1148/radiol.11110416. Epub 2011 Oct 13.

    PubMed 21998044

  • Jeong WK, Baek JH, Rhim H, Kim YS, Kwak MS, Jeong HJ, Lee D. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol. 2008 Jun;18(6):1244-50. doi: 10.1007/s00330-008-0880-6. Epub 2008 Feb 20.

    PubMed 18286289

  • Deandrea M, Sung JY, Limone P, Mormile A, Garino F, Ragazzoni F, Kim KS, Lee D, Baek JH. Efficacy and Safety of Radiofrequency Ablation Versus Observation for Nonfunctioning Benign Thyroid Nodules: A Randomized Controlled International Collaborative Trial. Thyroid. 2015 Aug;25(8):890-6. doi: 10.1089/thy.2015.0133. Epub 2015 Jul 13.

    PubMed 26061686

  • Baek JH, Lee JH, Valcavi R, Pacella CM, Rhim H, Na DG. Thermal ablation for benign thyroid nodules: radiofrequency and laser. Korean J Radiol. 2011 Sep-Oct;12(5):525-40. doi: 10.3348/kjr.2011.12.5.525. Epub 2011 Aug 24.

    PubMed 21927553

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Thyroid Nodule, run by University Hospital, Ghent at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Charlotte Harth, MD (+32 9 332 0450, studies.vinrad@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07237373, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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