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Hyperthyroidism/ThyrotoxicosisNCT06305871

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

A study testing Ablation therapy in people with Hyperthyroidism/Thyrotoxicosis, run by Zhang Bo at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hyperthyroidism/Thyrotoxicosis
What is being tested?
Ablation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Aug 2023to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Poor general condition
  • early and late pregnancy
  • The retrosternal thyroid or thyroid gland is mostly behind the sternum
  • Incomplete function of one vocal cord
  • severe coagulation dysfunction
  • Malignant exophthalmia
  • Adolescent patients
  • Patients requiring urgent relief of symptoms of oppression.

Trial locations and contacts

1 site in 1 country.

China1 site
  • China-Japan friendship hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

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.

Being tested
Ablation therapy
Keywords
Hyperthyroidism, Ultrasound-guided ablation
Medical subject headings
Hyperthyroidism, Thyrotoxicosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation therapyProcedure or surgery

    Ablative treatment of hyperthyroidism

Study groups in NCT06305871
Study groupRoleWhat they receive
Ablation groupExperimentalPatients with hyperthyroidism undergoing ultrasound-guided ablation
Receives: Procedure: Ablation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Discontinuation rate

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

    Measured: two years

  2. Recurrence rate

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

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 Aug 2023
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305871
Sponsor's protocol ID
2023-NHLHCRF-YYPPLC-ZR-09
Status last verified
Mar 2024
First submitted
5 Feb 2024
Last updated
12 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ablation therapy in people with Hyperthyroidism/Thyrotoxicosis, run by Zhang Bo at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discontinuation rate (time frame: two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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