Ablation Techniques, RFANCT07804862
Efficacy and Safety of RFA vs MWA for Treatment of Large Benign Thyroid Nodules, RCT
A study testing Radiofrequency ablation alone and Microwave ablation in people with Ablation Techniques, RFA and Ablation Treatment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
We conduct a multi-institutional randomized control trial of RFA and MWA for the primary treatment of large, benign nodules. Adult patients >/=18 years of age who have a solitary thyroid nodule ≥20ml in volume who presents to 1) Columbia University, NY or 2) Queen Mary Hospital, Hong Kong for consultation will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ablation Techniques, RFA, Ablation Treatment, Benign Thyroid Nodules
- What is being tested?
- Radiofrequency ablation alone and Microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Dec 2023to 30 Mar 2027
- Phase
- Interventional
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
Who may be able to join
- who have a solitary thyroid nodule ≥20ml in volume
- two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
- Both functional and non-functional nodules are eligible
Who cannot join
- have multiple nodules and planned simultaneous ablation
- cytologically indeterminate thyroid nodules
- nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
- current pregnancy or cardiac arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy and Safety of Radiofrequency Ablation Versus Microwave Ablation for the Treatment of Large Benign Thyroid Nodules, a Randomized Controlled Trial
We conduct a multi-institutional randomized control trial of RFA and MWA for the primary treatment of large, benign nodules. Adult patients >/=18 years of age who have a solitary thyroid nodule ≥20ml in volume who presents to 1) Columbia University, NY or 2) Queen Mary Hospital, Hong Kong for consultation will be eligible for enrollment in the study. They will need either a) two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or b) one benign fine needle biopsy and low suspicion characteristics on ultrasound. Both functional and non-functional nodules are eligible.
Patients will be randomly assigned to either treatment arm a) RFA or treatment arm b) MWA according to a pre-generated block randomization list.
Read the detailed description
Benign thyroid nodules can cause compressive symptoms for patients, including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. Some nodules will become autonomously functioning causing hyperthyroidism. Traditionally the gold standard treatment for these benign, but problematic nodules, has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation.
Introduced in the early 2000s, ultrasound-guided percutaneous ablation of thyroid lesions has emerged as a potential alternative to surgery in patients with benign thyroid nodules. Of the myriad ablation methods, the most commonly used technique are radiofrequency ablation (RFA) and microwave ablation (MWA). The two techniques used different mechanisms for heat generation.
Current evidence comparing RFA versus MWA for thyroid ablation were limited and were either retrospective or non-randomized, with focus mainly on small thyroid nodules of ≤10ml in volume. There is a lack of high quality evidence on the safety and efficacy of RFA versus MWA for the treatment of large thyroid nodules (≥20ml).
The aim of this randomized controlled trial is to compare the safety and efficacy of RFA and MWA in the treatment of large, benign thyroid nodules.
The primary outcome of is the volume reduction rate at 6 months after ablation. The secondary outcomes include safety, complication rates and quality of life after both procedures.
- Being tested
- Radiofrequency ablation alone, Microwave ablation
- Keywords
- RFA, MWA, LA, compressive symptoms, Large benign thyroid nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneDevice
Also called RFA
Ultrasound-guided thermal ablation will be performed using STARmed internally cooled RFA electrodes (18 gauge) powered by the VIVA RF generator in accordance with the trans-isthmic 'moving shot' technique.
Microwave ablationDevice
Also called MWA
Ultrasound-guided thermal ablation will be performed using ECO Medical internally cooled MWA antennas (16 or 17 gauge) powered by the ECO Medical generator in accordance with the trans-isthmic 'moving shot' technique.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Experimental | Apply microwave ablation to those large benign thyroid nodules for shrinkage purpose Receives: Device: Microwave ablation |
| Radiofrequency ablation | Experimental | Apply radiofrequency ablation to those large benign thyroid nodules for shrinkage purpose Receives: Device: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction rate (VRR) of thyroid nodule at 6 months (%)
To measure the volume reduction rate (VRR) of thyroid nodule at 6-month.
volume of nodule= length(cm) x width(cm) x depth(cm) x (π / 6 ) VRR = [(volume at baseline - volume at 6-month)/volume of baseline] x 100%
Measured: 6 months
Secondary outcomes (5)
Volume reduction rate (VRR) of thyroid nodule at 12 months (%)
To measure the volume reduction rate (VRR) of thyroid nodule at 12-month. volume of nodule= length(cm) x width(cm) x depth(cm) x (π / 6 ) VRR = [(volume at baseline - volume at 12-m / Volume at baseline] x 100%
Measured: 12-months
Changes in compressive symptom scores (0-100)
To measure the changes in compressive symptoms scores. Compressive symptoms score is from 0 to 100. The higher score means more compressive symptom.
Measured: 12 months
Changes in cosmetic symptom scores (1-4)
To assess the change of cosmetic symptom by experienced doctors until 12 months.
Cosmetic symptoms is from 1 to 4 as below
- = no palpable goitre
- = Palpable goiter but invisible
- = Goitre only visible to experienced clinician
- = Easily visible goitre
Measured: 12 months
Peri-operative pain scores (0-10)
To measure the change in pain score before and after ablation. The pain score is from 0 to 10, the higher score means more painful.
Measured: 12 months
Complications from procedure including vocal cord palsy, bleeding, infection, nodule rupture, skin burn
Description: To assess for any complications arising from procedure during follow-up period after ablation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start5 Dec 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ablation Techniques, RFAStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Man Him Matrix Fung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804862
- Sponsor's protocol ID
- UW 23-574
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheng Z, Che Y, Yu S, Wang S, Teng D, Xu H, Li J, Sun D, Han Z, Liang P. US-Guided Percutaneous Radiofrequency versus Microwave Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study. Sci Rep. 2017 Aug 25;7(1):9554. doi: 10.1038/s41598-017-09930-7.
PubMed 28842651Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23.
PubMed 29333159He L, Zhao W, Xia Z, Su A, Li Z, Zhu J. Comparative efficacy of different ultrasound-guided ablation for the treatment of benign thyroid nodules: Systematic review and network meta-analysis of randomized controlled trials. PLoS One. 2021 Jan 20;16(1):e0243864. doi: 10.1371/journal.pone.0243864. eCollection 2021.
PubMed 33471820Hu K, Wu J, Dong Y, Yan Z, Lu Z, Liu L. Comparison between ultrasound-guided percutaneous radiofrequency and microwave ablation in benign thyroid nodules. J Cancer Res Ther. 2019;15(7):1535-1540. doi: 10.4103/jcrt.JCRT_322_19.
PubMed 31939434Guo DM, Chen Z, Zhai YX, Su HH. Comparison of radiofrequency ablation and microwave ablation for benign thyroid nodules: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2021 Jul;95(1):187-196. doi: 10.1111/cen.14438. Epub 2021 Mar 2.
PubMed 33556187Jin H, Fan J, Lu L, Cui M. A Propensity Score Matching Study Between Microwave Ablation and Radiofrequency Ablation in Terms of Safety and Efficacy for Benign Thyroid Nodules Treatment. Front Endocrinol (Lausanne). 2021 Mar 9;12:584972. doi: 10.3389/fendo.2021.584972. eCollection 2021.
PubMed 33767666Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14.
PubMed 29962870Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21.
PubMed 22438360Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25.
PubMed 23096937