Benign Thyroid NodulesRFATNCT07115576
Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study
A study testing Radiofrequency ablation alone in people with Benign Thyroid Nodules, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Title: Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study Purpose: The goal of this clinical trial is to learn if single-session radiofrequency ablation (RFA) can effectively reduce the volume of benign thyroid nodules in adults. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Thyroid Nodules
- What is being tested?
- Radiofrequency ablation alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Feb 2023to 10 Apr 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with thyroid nodules, confirmed by ultrasound.
- Presence of compressive symptoms (e.g., dysphagia, neck pressure) or cosmetic concerns.
- Documented thyroid function tests (serum free thyroxine [FT4] and thyrotropin [TSH]).
- Cytology-confirmed benign thyroid nodules via one or two ultrasound-guided fine-needle aspiration (FNA) procedures.
- Refusal of surgical treatment.
- Ability to complete follow-up assessments at 1, 6, and 12 months post-procedure.
Who cannot join
- Malignant or indeterminate cytology on FNA.
- Contraindications to RFA (e.g., severe coagulopathy, pregnancy).
- Uncontrolled thyroid dysfunction (e.g., hyperthyroidism or hypothyroidism).
- Inability to provide informed consent or comply with follow-up
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Hue University of Medicine and Pharmacy, Hue University,
Huế, 49000
About this study
Title:
Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study
Read more
Purpose:
The goal of this clinical trial is to learn if single-session radiofrequency ablation (RFA) can effectively reduce the volume of benign thyroid nodules in adults. It will also evaluate the safety of the RFA procedure.
The main questions it aims to answer are:
- Does RFA procedure reduce the size of thyroid nodules (measured by volume reduction rate - VRR)?
- What medical problems or complications do participants experience after undergoing RFA?
- How does RFA affect thyroid hormone levels (TSH, FT4)?
- Is RFA equally effective in purely cystic nodules, solid nodules, and predominantly cystic nodules?
Comparator:
This is a single-arm study, so there is no placebo or comparison treatment group. All participants will undergo RFA, and the results will be assessed over time.
Participants will:
- Undergo one session of RFA for benign thyroid nodules.
- Be followed up with clinical visits and ultrasound assessments at 1, 6, and 12 months.
- Have thyroid hormone levels tested and nodule size measured by ultrasound at each follow-up.
- Be monitored for any side effects or complications such as voice changes, pain, or bleeding.
- Conditions
- Benign Thyroid Nodules
- Being tested
- Radiofrequency ablation alone
- Keywords
- Benign thyroid nodules, Radiofrequency Ablation, Prospective Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
Also called RFA
Radiofrequency ablation (RFA) is a minimally invasive procedure used to treat benign thyroid nodules without surgery. It involves inserting a thin, needle-like electrode into the nodule under ultrasound guidance. Using high-frequency alternating current, the electrode generates heat to destroy targeted thyroid tissue, causing the nodule to shrink over time.
| Study group | Role | What they receive |
|---|---|---|
| primary end-point | Experimental | To evaluate the efficacy of RFA procedure in reducing the volume of benign cystic thyroid nodules, measured by the volume reduction rate (VRR) at 1, 6, and 12 months post-procedure. Receives: Procedure: Radiofrequency ablation alone |
| Secondary end-point | Experimental | • To assess the safety of RFA procedure, including the incidence of major and minor complications. Receives: Procedure: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume Reduction Rate (VRR)
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline:
VRR (%) = [(Initial Volume - Follow-up Volume) / Initial Volume] × 100
In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
Measured: 1 month; 6 months; 12 months
volume reduction rate (VRR) at 1, 6, and 12 months post-procedure.
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline:
VRR (%) = [(Initial Volume - Follow-up Volume) / Initial Volume] × 100
In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
Measured: 1 month; 6 months; 12 months
Secondary outcomes (1)
Assess the safety of single-session RFA
The safety of radiofrequency ablation (RFA) procedure for benign thyroid nodules is evaluated by monitoring the incidence and severity of complications following the procedure. Complications are classified as major (e.g., permanent voice changes, significant bleeding requiring intervention, hospitalization) or minor (e.g., transient pain, temporary voice hoarseness, mild swelling).
All adverse events are recorded during and after the procedure, and at follow-up visits at 1, 6, and 12 months. Safety assessments follow international guidelines for image-guided tumor ablation. The absence of serious complications and a low rate of minor, self-limiting events indicate that single-session RFA is a safe and well-tolerated alternative to surgery for selected patients with benign thyroid nodules.
Measured: 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start10 Feb 2023
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Thyroid NodulesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Da Nang Family General Hospital
- Responsible party
- Principal investigator, Le Van Chi, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115576
- Sponsor's protocol ID
- H2023/050
- Acronym
- RFAT
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen VB, Le TB, Van CL. Single-session radiofrequency ablation for the treatment of benign cystic thyroid nodules: A prospective study. PLoS One. 2026 Feb 4;21(2):e0341556. doi: 10.1371/journal.pone.0341556. eCollection 2026.
PubMed 41637422
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study
- ClinicalTrials.gov ID
- NCT07115576
- Acronym / sponsor ID
- RFAT / H2023/050
- Conditions
- Benign Thyroid Nodules
- Keywords
- Benign thyroid nodules, Radiofrequency Ablation, Prospective Study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Da Nang Family General Hospital
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title:
Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study
Purpose:
The goal of this clinical trial is to learn if single-session radiofrequency ablation (RFA) can effectively reduce the volume of benign thyroid nodules in adults. It will also evaluate the safety of the RFA procedure.
The main questions it aims to answer are:
- Does RFA procedure reduce the size of thyroid nodules (measured by volume reduction rate - VRR)?
- What medical problems or complications do participants experience after undergoing RFA?
- How does RFA affect thyroid hormone levels (TSH, FT4)?
- Is RFA equally effective in purely cystic nodules, solid nodules, and predominantly cystic nodules?
Comparator:
This is a single-arm study, so there is no placebo or comparison treatment group. All participants will undergo RFA, and the results will be assessed over time.
Participants will:
- Undergo one session of RFA for benign thyroid nodules.
- Be followed up with clinical visits and ultrasound assessments at 1, 6, and 12 months.
- Have thyroid hormone levels tested and nodule size measured by ultrasound at each follow-up.
- Be monitored for any side effects or complications such as voice changes, pain, or bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary end-point | Experimental | Procedure: Radiofrequency ablation aloneTo evaluate the efficacy of RFA procedure in reducing the volume of benign cystic thyroid nodules, measured by the volume reduction rate (VRR) at 1, 6, and 12 months post-procedure. |
| Secondary end-point | Experimental | Procedure: Radiofrequency ablation alone• To assess the safety of RFA procedure, including the incidence of major and minor complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with thyroid nodules, confirmed by ultrasound.
- Presence of compressive symptoms (e.g., dysphagia, neck pressure) or cosmetic concerns.
- Documented thyroid function tests (serum free thyroxine [FT4] and thyrotropin [TSH]).
- Cytology-confirmed benign thyroid nodules via one or two ultrasound-guided fine-needle aspiration (FNA) procedures.
- Refusal of surgical treatment.
Key exclusion criteria (4 listed)
- Malignant or indeterminate cytology on FNA.
- Contraindications to RFA (e.g., severe coagulopathy, pregnancy).
- Uncontrolled thyroid dysfunction (e.g., hyperthyroidism or hypothyroidism).
- Inability to provide informed consent or comply with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation aloneAlso: RFARadiofrequency ablation (RFA) is a minimally invasive procedure used to treat benign thyroid nodules without surgery. It involves inserting a thin, needle-like electrode into the nodule under ultrasound guidance. Using high-frequency alternating current, the electrode generates heat to destroy targeted thyroid tissue, causing the nodule to shrink over time. | Procedure or surgery | Secondary end-point, primary end-point |
Primary outcome
Volume Reduction Rate (VRR)
Time frame: 1 month; 6 months; 12 months
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline: VRR (%) = [(Initial Volume - Follow-up Volume) / Initial Volume] × 100 In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
volume reduction rate (VRR) at 1, 6, and 12 months post-procedure.
Time frame: 1 month; 6 months; 12 months
The volume reduction rate (VRR) is used to assess the effectiveness of radiofrequency ablation (RFA) in shrinking thyroid nodules over time. It is calculated as the percentage decrease in nodule volume compared to baseline: VRR (%) = [(Initial Volume - Follow-up Volume) / Initial Volume] × 100 In this study, VRR will be measured at 1, 6, and 12 months after the RFA procedure using ultrasound. A VRR greater than 50% is generally considered a successful therapeutic outcome. Tracking VRR at these time points helps evaluate the progressive reduction in nodule size and the long-term efficacy of the treatment.
1 secondary outcome
Assess the safety of single-session RFA
Time frame: 1 month, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 41637422Nguyen VB, Le TB, Van CL. Single-session radiofrequency ablation for the treatment of benign cystic thyroid nodules: A prospective study. PLoS One. 2026 Feb 4;21(2):e0341556. doi: 10.1371/journal.pone.0341556. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone in people with Benign Thyroid Nodules, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume Reduction Rate (VRR) (time frame: 1 month; 6 months; 12 months). The study lists 2 primary outcomes in all. 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 NCT07115576, which also lists 1 linked publication.
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 16 Dec 2025.