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Active, not recruitingNCT07115576RFATUpdated Dec 16, 2025

Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study

An interventional study of Radiofrequency ablation alone in Benign Thyroid Nodules, sponsored by Hue University of Medicine and Pharmacy. Active, not recruiting at 1 site in Vietnam. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Hue University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as active, not recruiting.
  • Registered 2 years 5 months after the study started (first participant enrolled Feb 2023, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Non-randomized
Sex
All
01

Study 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. It will also evaluate the safety of the RFA procedure.

The main questions it aims to answer are:

  1. Does RFA procedure reduce the size of thyroid nodules (measured by volume reduction rate - VRR)?
  2. What medical problems or complications do participants experience after undergoing RFA?
  3. How does RFA affect thyroid hormone levels (TSH, FT4)?
  4. 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.
02

Conditions studied

  • Benign Thyroid Nodules

Keywords

  • Benign thyroid nodules
  • Radiofrequency Ablation
  • Prospective Study
03

In context

Lead sponsor

Hue University of Medicine and Pharmacy is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    primary end-point

    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.

    Procedure: Radiofrequency ablation alone

  • Experimental
    Secondary end-point

    • To assess the safety of RFA procedure, including the incidence of major and minor complications.

    Procedure: Radiofrequency ablation alone

Interventions

  • ProcedureRadiofrequency ablation alone

    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.

    Also known as: RFA

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month; 6 months; 12 months

  2. 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.

    Time frame: 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.

    Time frame: 1 month, 6 months, 12 months

07

Study locations

1 site
  • Hue University of Medicine and Pharmacy, Hue University,
    Huế, 49000, Vietnam
08

References and documents

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 documents

  • Protocol and statistical analysis plan · Feb 10, 2023
  • Protocol and statistical analysis plan · Dec 8, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07115576
Lead sponsor
Hue University of Medicine and Pharmacy
Collaborators
Da Nang Family General Hospital
Responsible party
Le Van Chi (professor, Hue University of Medicine and Pharmacy) — Principal investigator
First posted
Aug 11, 2025
Start date
Feb 10, 2023
Primary completion
Feb 10, 2026 (estimated)
Completion
Apr 10, 2026 (estimated)
Last update
Dec 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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