Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study
NCT ID: NCT07115576
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
106 participants
INTERVENTIONAL
2023-02-10
2026-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Radiofrequency 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.
Secondary end-point
• To assess the safety of RFA procedure, including the incidence of major and minor complications.
Radiofrequency 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiofrequency 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Da Nang Family Hospital
UNKNOWN
Hue University of Medicine and Pharmacy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Le Van Chi
professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hue University of Medicine and Pharmacy, Hue University,
Huế, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Study Protocol and Statistical Analysis Plan: study protocol and Statistical Analysis Plan version 2
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H2023/050
Identifier Type: -
Identifier Source: org_study_id