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Active, not recruitingNCT06305871Updated Mar 12, 2024

Clinical Study of Ultrasound-guided Radiofrequency Ablation in the Treatment of Refractory Hyperthyroidism

An interventional study of Ablation therapy in Hyperthyroidism/Thyrotoxicosis, sponsored by Zhang Bo. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Primary conditionThyrotoxicosisRegistry: HyperthyroidismReclassifiedWhy we changed it
Registry
Hyperthyroidism — the first condition term the registry derived for this study.
ClinicalTrials.gg
Thyrotoxicosis
Why
  1. The study's listed conditions name Thyrotoxicosis, a narrower term within Hyperthyroidism.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Zhang Bo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
  • Registered 6 months after the study started (first participant enrolled Aug 2023, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Hyperthyroidism is an endocrine disease with a high incidence rate, and some patients are difficult to effectively control the condition after long-term drug treatment, and the disease recurs, forming refractory hyperthyroidism. The search for a new safe, effective and minimally invasive treatment has become a research hotspot. Ultrasound-guided radiofrequency ablation is a hot spot in clinical research due to its advantages of low trauma, high safety, precise inactivation of lesions, and multiple ablation. However, there is no unified standard for the number and scope of ablation in the treatment of refractory hyperthyroidism by radiofrequency ablation, and there is a lack of data on the effectiveness and safety of the treatment with large samples and long-term effects. Therefore, how to establish a standardized treatment strategy and appropriate plan for ablation of refractory hyperthyroidism based on clinical practice is an urgent problem to be solved. The purpose of this study was to prospectively include refractory hyperthyroidism for ultrasound-guided radiofrequency ablation, and to evaluate the efficacy and safety of hyperthyroidism ablation by comparing the changes in symptoms and signs, serology, and imaging of patients before and after ablation. The relevant factors affecting the efficacy of ablation were analyzed and the most appropriate ablation scope was determined. Radiofrequency ablation was retrospectively compared with traditional surgery and 131I treatment, and the near- and medium-term treatment effects, incidence of adverse reactions and complications, as well as the economic benefits and sociopsychological differences of the three treatment methods were compared.

The expected outcome of this study is to establish a research cohort of hyperthyroidism ablation based on a large sample population, and to establish the most appropriate and effective regimen for radiofrequency ablation of refractory hyperthyroidism compared with traditional surgery and 131I treatment with safety and near- and medium-term efficacy. The Department of Ultrasound Medicine of China-Japan Friendship Hospital has accumulated rich experience in the ablation treatment of benign and malignant thyroid nodules and hyperthyroidism, and has completed more than 200 cases of thyroid ablation in the past two years. Under the leadership of Professor Zhang Bo, the research team of this project has conducted a number of clinical studies on the ultrasound diagnosis and treatment of thyroid diseases, presided over and participated in more than 20 national, provincial and university-level scientific research courses, and the first author or corresponding author wrote more than 70 articles in related fields, which laid a solid research foundation for the conduct of this study.

02

Conditions studied

  • Hyperthyroidism/Thyrotoxicosis

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Keywords

  • Hyperthyroidism
  • Ultrasound-guided ablation
03

In context

Thyrotoxicosis Reclassified

21 studies on the registry are indexed under Thyrotoxicosis; 5 are open to participants now.

Browse Thyrotoxicosis studies →

Lead sponsor

This is the only study on the registry with Zhang Bo as lead sponsor.

Compared within Thyrotoxicosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperthyroidism. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Poor effect and recurrence after medical standard treatment
  2. serious adverse reaction to drug treatment
  3. poor effect of iodine-131 treatment
  4. Patients who wish to undergo ablation surgery to shorten the duration of treatment and improve symptoms
  5. Moderate to severe active Graves ophthalmopathy
  6. Second trimester patients

Exclusion criteria

Exclusion Criteria:

  1. Poor general condition
  2. early and late pregnancy
  3. The retrosternal thyroid or thyroid gland is mostly behind the sternum
  4. Incomplete function of one vocal cord
  5. severe coagulation dysfunction
  6. Malignant exophthalmia
  7. Adolescent patients
  8. Patients requiring urgent relief of symptoms of oppression.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ablation group

    Patients with hyperthyroidism undergoing ultrasound-guided ablation

    Procedure: Ablation therapy

Interventions

  • ProcedureAblation therapy

    Ablative treatment of hyperthyroidism

06

What researchers measure

Primary outcomes

  1. Discontinuation rate

    Discontinuation rate in patients with hyperthyroidism ablation for six months after surgery

    Time frame: two years

  2. Recurrence rate

    Recurrence rate in patients with hyperthyroidism ablation half a year after discontinuation of the drug

    Time frame: two years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Jul 2025, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2024
First posted
Mar 12, 2024
StartActual
Aug 1, 2023
Primary completionEst.
Jul 31, 2025
CompletionEst.
Jul 31, 2025
Last update
Mar 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06305871
Lead sponsor
Zhang Bo
Responsible party
Zhang Bo (Chief Physician, China-Japan Friendship Hospital) — Sponsor-investigator
First posted
Mar 12, 2024
Start date
Aug 1, 2023
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Mar 12, 2024

Oversight

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 Mar 2024. You cannot join it, but the record below documents what was studied.

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