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

NCT07115576 | Active Not Recruiting

• 1 other identifier: H2023/050
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Benign thyroid nodules; Radiofrequency Ablation; Prospective Study

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 month; 6 months; 12 months

Secondary Outcomes (1)

• Assess the safety of single-session RFA

  1 month, 6 months, 12 months

Study Arms (2)

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.

Procedure: Radiofrequency ablation alone

Secondary end-point

EXPERIMENTAL

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

Procedure: Radiofrequency ablation alone

Interventions

Radiofrequency ablation alone PROCEDURE

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

Secondary end-point; primary end-point

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead
• Da Nang Family General Hospital: collaborator

Study Sites (1)

Hue University of Medicine and Pharmacy, Hue University,

Huế, 49000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 41637422 DERIVED

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: February 10, 2023
• Primary Completion: February 10, 2026
• Study Completion: April 10, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)