Thyroid Nodule (Diagnosis)NCT07906821
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
A study testing ultrasound-guided percutaneous microwave ablation (MWA) in people with Thyroid Nodule (Diagnosis), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to learn if microwave ablation of benign thyroid nodules under local anaesthesia is a safe and effective procedure compared to open thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule (Diagnosis)
- What is being tested?
- ultrasound-guided percutaneous microwave ablation (MWA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Aug 2023to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroid nodules or dominant nodule of multinodular goitre
- Symptomatic thyroid nodule not less than 2cm
- Benign thyroid nodule confirmed by Fine needle aspiration for cytology (FNAC)
Who cannot join
- Asymptomatic thyroid nodule
- Malignant thyroid nodule
- High risk USG features or cytological features
- Previous anterior neck surgery
- Previous radiotherapy at the head and neck region
- Presence of another malignancy, lateral neck, or distant metastasis
Show all 12Show fewer
- Cervical spine disease precluding extension of the neck
- Patients under 18 years old
- Vulnerable population (e.g. Cognitive impairment, pregnancy)
- Obesity with BMI > 35kg/m2
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Non-correctable coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chines University of Hong Kong
Shatin
Cherrie Ng, 852 + 35051409, cherrieng@cuhk.edu.hk
About this study
The goal of this clinical trial is to learn if microwave ablation of benign thyroid nodules under local anaesthesia is a safe and effective procedure compared to open thyroidectomy.
The main questions it aims to answer are:
Read more
Dose microwave Ablation effectively cause shrinkage of thyroid nodules? Can ablation of selective area of nodules be safely performed under ultrasound guidance, avoiding critical structures including recurrent laryngeal nerve, major vessels and trachea? Researchers will recruit subjects with symptomatic benign thyroid nodules for Microwave Ablation.
Participants will:
Undergo ultrasound guided Microwave Ablation of benign thyroid nodules. Visit the clinic at post operation 2-week, 3-month, 6-month, 12-month, 2-year and 3-year for checkups and tests.
Fill in questionnaire at each clinic visit for pain, pressure symptoms, cosmetic overall satisfaction in Visual Analog Scale.
Read the detailed description
Benign thyroid nodules are common in the general population. Some of them can cause significant patient concerns including compression symptoms and cosmetic issues. Traditional treatment of symptomatic benign thyroid nodules has been surgical excision which is a procedure under general anaesthesia and carries peri-operative complications. Microwave ablation (MWA) is a minimally invasive procedure, which is used for benign and malignant tumors of liver and lung. It has gained attention among otolaryngologists as it could be a minimally invasive procedure under local anaesthesia and effectively causes shrinkage of thyroid nodules, according to some recent studies. Ablation of selective area of nodules can be safely performed under ultrasound guidance, avoiding critical structures including recurrent laryngeal nerve, major vessels and trachea. Effect of ablation could also be 'visualized' real time with ultrasound images.
This is a prospective study. There is one arm, Microwave Ablation of thyroid nodules. We will recruit 60 subjects with symptomatic benign thyroid nodules for Microwave Ablation.
Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea.
Participants will have clinic visit at post operation 2-week 3-month, 6-month, 12-month, 2-year and 3-year for checkups and tests.
- Conditions
- Thyroid Nodule (Diagnosis)
- Being tested
- ultrasound-guided percutaneous microwave ablation (MWA)
- Keywords
- Microwave ablation
- Medical subject headings
- Thyroid Nodule, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided percutaneous microwave ablation (MWA)Procedure or surgery
Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. Ablation is carried out one axial plane at a time, from inferior to superior aspect of the targeted lesion. Within each axial plane, ablation is performed from deep to superficial manner to prevent bubble generated by the ablation from hindering ultrasound examination. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea. During the procedure, the patient's vital signs including O2 saturation, blood pressure and heart rate would be monitored. Operative procedures, difficulties encountered (if any) and operation time will be documented.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation | Experimental | Microwave ablation (MWA) is a minimally invasive, image-guided medical procedure that used to shrink benign (non-cancerous) thyroid nodules Receives: Procedure: ultrasound-guided percutaneous microwave ablation (MWA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid nodule volume reduction rate (VRR) at 3 months post operation
Thyroid nodule volume is measured via ultrasound and calculated using the ellipsoid formula (length × width × depth × π/6). Changes in nodule volume are expressed as the VRR (%) calculated using the following formula: (Baseline volume - nodule volume at 3 months post operation) × 100/ Baseline volume. This is the percentage measurement of how much a nodule has shrunk compared to its size before the procedure. A positive thyroid nodule volume reduction rate (VRR) means that the physical size (volume) of a thyroid nodule has successfully decreased following the operation. A negative thyroid nodule volume reduction rate (VRR) means that the size or volume of a thyroid nodule increased rather than shrank after a monitoring period.
Measured: Baseline and 3 months post operation
Secondary outcomes (4)
Procedure time of microwave ablation
Procedure time is defined as the duration from the insertion of the microwave ablation antenna into the patient until the removal of the antenna, measured in minutes.
Measured: At the time of operation (Day 0)
Pain intensity as assessed by the Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a self-reported instrument used to measure subjective pain intensity after the operation. The total score ranges from 0 to 10, where a score of 0 represents "no pain" and a score of 10 represents "the worst imaginable pain". Higher scores indicate greater pain severity. Maximum pain score recorded on the day of the microwave ablation procedure (Day 0)
Measured: Day 0
Overall Satisfaction Score of the operation at 3 years post operation
Overall satisfaction of the operation assessed using a Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied". A higher score represents a better outcome.
Measured: 3 years post operation
Change From Baseline in Visual Analog Scale (VAS) Score for Pressure Symptoms at 3 years post operation
The Visual Analog Scale (VAS) is used to self-report the severity of pressure symptoms. The scale ranges from 0 to 10, where 0 indicates "no symptoms" and 10 indicates "the most severe symptoms imaginable". Higher scores represent worse outcomes.
Measured: Baseline and 3 years post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start31 Aug 2023
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Microwave ablation procedure: Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. Ablation is carried out one axial plane at a time, from inferior to superior aspect of the targeted lesion. Within each axial plane, ablation is performed from deep to superficial manner to prevent bubble generated by the ablation from hindering ultrasound examination. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea. During the procedure, the patient's vital signs including O2 saturation, blood pressure and heart rate would be monitored. Operative procedures, difficulties encountered (if any) and operation time will be documented.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Chung Chie Cheng, Chinese University of Hong Kong
- Investigators
- Samuel Chung Chie Cheng, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906821
- Sponsor's protocol ID
- CREC 2023.196
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT07906821
- Acronym / sponsor ID
- CREC 2023.196
- Conditions
- Thyroid Nodule (Diagnosis)
- Keywords
- Microwave ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 30 Oct 2026 (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.
The goal of this clinical trial is to learn if microwave ablation of benign thyroid nodules under local anaesthesia is a safe and effective procedure compared to open thyroidectomy.
The main questions it aims to answer are:
Dose microwave Ablation effectively cause shrinkage of thyroid nodules? Can ablation of selective area of nodules be safely performed under ultrasound guidance, avoiding critical structures including recurrent laryngeal nerve, major vessels and trachea? Researchers will recruit subjects with symptomatic benign thyroid nodules for Microwave Ablation.
Participants will:
Undergo ultrasound guided Microwave Ablation of benign thyroid nodules. Visit the clinic at post operation 2-week, 3-month, 6-month, 12-month, 2-year and 3-year for checkups and tests.
Fill in questionnaire at each clinic visit for pain, pressure symptoms, cosmetic overall satisfaction in Visual Analog Scale.
Detailed description
Benign thyroid nodules are common in the general population. Some of them can cause significant patient concerns including compression symptoms and cosmetic issues. Traditional treatment of symptomatic benign thyroid nodules has been surgical excision which is a procedure under general anaesthesia and carries peri-operative complications. Microwave ablation (MWA) is a minimally invasive procedure, which is used for benign and malignant tumors of liver and lung. It has gained attention among otolaryngologists as it could be a minimally invasive procedure under local anaesthesia and effectively causes shrinkage of thyroid nodules, according to some recent studies. Ablation of selective area of nodules can be safely performed under ultrasound guidance, avoiding critical structures including recurrent laryngeal nerve, major vessels and trachea. Effect of ablation could also be 'visualized' real time with ultrasound images.
This is a prospective study. There is one arm, Microwave Ablation of thyroid nodules. We will recruit 60 subjects with symptomatic benign thyroid nodules for Microwave Ablation.
Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea.
Participants will have clinic visit at post operation 2-week 3-month, 6-month, 12-month, 2-year and 3-year for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Microwave ablation procedure: Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. Ablation is carried out one axial plane at a time, from inferior to superior aspect of the targeted lesion. Within each axial plane, ablation is performed from deep to superficial manner to prevent bubble generated by the ablation from hindering ultrasound examination. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea. During the procedure, the patient's vital signs including O2 saturation, blood pressure and heart rate would be monitored. Operative procedures, difficulties encountered (if any) and operation time will be documented.
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation | Experimental | Procedure: ultrasound-guided percutaneous microwave ablation (MWA)Microwave ablation (MWA) is a minimally invasive, image-guided medical procedure that used to shrink benign (non-cancerous) thyroid nodules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thyroid nodules or dominant nodule of multinodular goitre
- Symptomatic thyroid nodule not less than 2cm
- Benign thyroid nodule confirmed by Fine needle aspiration for cytology (FNAC)
Key exclusion criteria (12 listed)
- Asymptomatic thyroid nodule
- Malignant thyroid nodule
- High risk USG features or cytological features
- Previous anterior neck surgery
- Previous radiotherapy at the head and neck region
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 ablation (MWA)Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. Ablation is carried out one axial plane at a time, from inferior to superior aspect of the targeted lesion. Within each axial plane, ablation is performed from deep to superficial manner to prevent bubble generated by the ablation from hindering ultrasound examination. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea. During the procedure, the patient's vital signs including O2 saturation, blood pressure and heart rate would be monitored. Operative procedures, difficulties encountered (if any) and operation time will be documented. | Procedure or surgery | Microwave Ablation |
Primary outcome
Thyroid nodule volume reduction rate (VRR) at 3 months post operation
Time frame: Baseline and 3 months post operation
Thyroid nodule volume is measured via ultrasound and calculated using the ellipsoid formula (length × width × depth × π/6). Changes in nodule volume are expressed as the VRR (%) calculated using the following formula: (Baseline volume - nodule volume at 3 months post operation) × 100/ Baseline volume. This is the percentage measurement of how much a nodule has shrunk compared to its size before the procedure. A positive thyroid nodule volume reduction rate (VRR) means that the physical size (volume) of a thyroid nodule has successfully decreased following the operation. A negative thyroid nodule volume reduction rate (VRR) means that the size or volume of a thyroid nodule increased rather than shrank after a monitoring period.
4 secondary outcomes
Procedure time of microwave ablation
Time frame: At the time of operation (Day 0)
Pain intensity as assessed by the Visual Analog Scale (VAS)
Time frame: Day 0
Overall Satisfaction Score of the operation at 3 years post operation
Time frame: 3 years post operation
Change From Baseline in Visual Analog Scale (VAS) Score for Pressure Symptoms at 3 years post operation
Time frame: Baseline and 3 years post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
Samuel Chung Chie Cheng principal investigator
Chinese University of Hong Kong
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 (MWA) in people with Thyroid Nodule (Diagnosis), run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Chung Chie Cheng (852 + 95173435, ccc353@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid nodule volume reduction rate (VRR) at 3 months post operation (time frame: Baseline and 3 months post operation). 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 2 Nov 2026.