Benign Thyroid NodulesNCT04046354
Microwave vs. Radiofrequency Ablation for Benign Thyroid Nodules: A Multicenter Randomized Controlled Trial Study
A study testing Ultrasound-guided Percutaneous Microwave Ablation and Ultrasound-guided Percutaneous Radiofrequency Ablation in people with Benign Thyroid Nodules and Ablation, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Benign Thyroid Nodules, Ablation
- What is being tested?
- Ultrasound-guided Percutaneous Microwave Ablation and Ultrasound-guided Percutaneous Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years and ≤75 years
- The pathological diagnosis was benign thyroid nodules within 6 months
- Diameter ≥2cm, solid > 80%, the number of multiple nodules≤ 3
- Participate voluntarily and sign the informed consent
Who cannot join
- Coagulation mechanism disorder or bleeding tendency
- Patients with severe cardiopulmonary insufficiency
- Blood pressure cannot be effectively controlled
- abnormal liver function
- Blood glucose cannot be effectively controlled
- Abnormal thyroid function
Show all 13Show fewer
- Allergic history of ultrasound contrast agent
- Suspicious lymph node metastasis in the cervical region
- Abnormal contralateral vocal cord function
- Pregnant and lactating women
- Have participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment
- The researchers believe that there are any other factors that are not suitable for inclusion or that affect participants' participation in the study.
- Patients with inner pacemaker, hearing aid, metal stent, titanium clip, internal (external) steel plate and other metal objects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Microwave Ablation System
Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.
Read the detailed description
Ultrasound-guided minimally invasive treatment has accurate positioning, higher targeting, no need for general anesthesia, less trauma for patients, and more reliable efficacy.Currently, it mainly includes percutaneous anhydrous ethanol injection, radiofrequency ablation and microwave ablation for the treatment of thyroid nodules.Currently, radiofrequency ablation and microwave ablation are mainly used to treat thyroid nodules.
This study was a randomized, parallel, positive control, and non-inferiority multicenter clinical study.Radiofrequency ablation was used as the positive control.Follow-up was conducted at 1, 3, 6 and 12 months after ablation. The primary endpoint was the rate of nodule volume reduction at 12 months after surgery.
- Conditions
- Benign Thyroid Nodules, Ablation
- Being tested
- Ultrasound-guided Percutaneous Microwave Ablation, Ultrasound-guided Percutaneous Radiofrequency Ablation
- Keywords
- microwave, thyroid
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Percutaneous Microwave AblationDevice
Ultrasound-guided Percutaneous Microwave Ablation
Ultrasound-guided Percutaneous Radiofrequency AblationDevice
Ultrasound-guided Percutaneous Radiofrequency Ablation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The group will use microwave ablation equipment to treat benign thyroid nodules. Receives: Device: Ultrasound-guided Percutaneous Microwave Ablation |
| Group B | Active comparator | The group will use radiofrequency ablation equipment to treat benign thyroid nodules. Receives: Device: Ultrasound-guided Percutaneous Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction rate of thyroid nodules
volume reduction rate，VRR=(Volume before treatment - volume at follow-up)/Volume before treatment
Measured: up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Aug 2019
- Primary completion19 Nov 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Jie, Chinese PLA General Hospital
- Investigators
- Jie Yu, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046354
- Sponsor's protocol ID
- KY2018001
- Status last verified
- Mar 2021
- First submitted
- 5 Aug 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rastogi A, Bhadada SK, Bhansali A. Nodular goiter with multiple cystic and solid swellings. Indian J Endocrinol Metab. 2012 Jul;16(4):651-3. doi: 10.4103/2230-8210.98034.
PubMed 22837936Kihara M, Hirokawa M, Masuoka H, Yabuta T, Shindo H, Higashiyama T, Fukushima M, Yamada O, Takamura Y, Ito Y, Kobayashi K, Miya A, Miyauchi A. Evaluation of cytologically benign solitary thyroid nodules by ultrasonography: a retrospective analysis of 1877 cases. Auris Nasus Larynx. 2013 Jun;40(3):308-11. doi: 10.1016/j.anl.2012.09.007. Epub 2012 Oct 24.
PubMed 23103151Wright AS, Sampson LA, Warner TF, Mahvi DM, Lee FT Jr. Radiofrequency versus microwave ablation in a hepatic porcine model. Radiology. 2005 Jul;236(1):132-9. doi: 10.1148/radiol.2361031249.
PubMed 15987969Chen S, Dou J, Cang Y, Che Y, Dong G, Zhang C, Xu D, Long Q, Yu J, Liang P. Microwave versus Radiofrequency Ablation in Treating Predominantly Solid Benign Thyroid Nodules: A Randomized Controlled Trial. Radiology. 2024 Oct;313(1):e232162. doi: 10.1148/radiol.232162.
PubMed 39436295
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Microwave Ablation System
- ClinicalTrials.gov ID
- NCT04046354
- Acronym / sponsor ID
- KY2018001
- Conditions
- Benign Thyroid Nodules, Ablation
- Keywords
- microwave, thyroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.
Detailed description
Ultrasound-guided minimally invasive treatment has accurate positioning, higher targeting, no need for general anesthesia, less trauma for patients, and more reliable efficacy.Currently, it mainly includes percutaneous anhydrous ethanol injection, radiofrequency ablation and microwave ablation for the treatment of thyroid nodules.Currently, radiofrequency ablation and microwave ablation are mainly used to treat thyroid nodules.
This study was a randomized, parallel, positive control, and non-inferiority multicenter clinical study.Radiofrequency ablation was used as the positive control.Follow-up was conducted at 1, 3, 6 and 12 months after ablation. The primary endpoint was the rate of nodule volume reduction at 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Ultrasound-guided Percutaneous Microwave AblationThe group will use microwave ablation equipment to treat benign thyroid nodules. |
| Group B | Active comparator | Device: Ultrasound-guided Percutaneous Radiofrequency AblationThe group will use radiofrequency ablation equipment to treat benign thyroid nodules. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18 years and ≤75 years
- The pathological diagnosis was benign thyroid nodules within 6 months
- Diameter ≥2cm, solid > 80%, the number of multiple nodules≤ 3
- Participate voluntarily and sign the informed consent
Key exclusion criteria (13 listed)
- Coagulation mechanism disorder or bleeding tendency
- Patients with severe cardiopulmonary insufficiency
- Blood pressure cannot be effectively controlled
- abnormal liver function
- Blood glucose cannot be effectively controlled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided Percutaneous Microwave AblationUltrasound-guided Percutaneous Microwave Ablation | Device | Group A |
| Ultrasound-guided Percutaneous Radiofrequency AblationUltrasound-guided Percutaneous Radiofrequency Ablation | Device | Group B |
Primary outcome
Volume reduction rate of thyroid nodules
Time frame: up to 12 months.
volume reduction rate，VRR=(Volume before treatment - volume at follow-up)/Volume before treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 22837936Rastogi A, Bhadada SK, Bhansali A. Nodular goiter with multiple cystic and solid swellings. Indian J Endocrinol Metab. 2012 Jul;16(4):651-3. doi: 10.4103/2230-8210.98034.
- Background: PubMed 23103151Kihara M, Hirokawa M, Masuoka H, Yabuta T, Shindo H, Higashiyama T, Fukushima M, Yamada O, Takamura Y, Ito Y, Kobayashi K, Miya A, Miyauchi A. Evaluation of cytologically benign solitary thyroid nodules by ultrasonography: a retrospective analysis of 1877 cases. Auris Nasus Larynx. 2013 Jun;40(3):308-11. doi: 10.1016/j.anl.2012.09.007. Epub 2012 Oct 24.
- Background: PubMed 15987969Wright AS, Sampson LA, Warner TF, Mahvi DM, Lee FT Jr. Radiofrequency versus microwave ablation in a hepatic porcine model. Radiology. 2005 Jul;236(1):132-9. doi: 10.1148/radiol.2361031249.
- Derived from this study: PubMed 39436295Chen S, Dou J, Cang Y, Che Y, Dong G, Zhang C, Xu D, Long Q, Yu J, Liang P. Microwave versus Radiofrequency Ablation in Treating Predominantly Solid Benign Thyroid Nodules: A Randomized Controlled Trial. Radiology. 2024 Oct;313(1):e232162. doi: 10.1148/radiol.232162.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Yu, Doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Percutaneous Microwave Ablation and Ultrasound-guided Percutaneous Radiofrequency Ablation in people with Benign Thyroid Nodules and Ablation, run by Chinese PLA General Hospital 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 4 inclusion and 13 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 3 Mar 2021. 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?
Volume reduction rate of thyroid nodules (time frame: up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046354, which also lists 4 linked publications.
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 3 Mar 2021.