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| Name | Class |
|---|---|
| Da Nang Family General Hospital | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Secondary end-point | Experimental | • To assess the safety of RFA procedure, including the incidence of major and minor complications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hue University of Medicine and Pharmacy, Hue University, | Huế | 49000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41637422 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2023 | Dec 7, 2025 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: study protocol and Statistical Analysis Plan version 2 | Dec 8, 2025 | Dec 7, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| 1 month, 6 months, 12 months |