Thyroid Nodule (Benign)NCT04233398
HIFU Treatment of Benign Thyroid Nodules
A study testing Device: Echopulse (HIFU ablation) in people with Thyroid Nodule (Benign), run by Theraclion.
Trial summary
This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Nodule (Benign)
- What is being tested?
- Device: Echopulse (HIFU ablation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Nov 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients older than 18 years and younger than 70 years
- No history of neck irradiation
- Normal thyroid function, serum calcitonin level, PTH and serum calcium at screening visit examination.
- No abnormal cervical lymph nodes during screening visit examination.
- The target thyroid nodule must meet all of the following conditions:
- Single nodule, 2cm≤max diameter≤4cm
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- Causing appearance , pressure or swallowing symptoms
- Composition of target nodule: solid or predominantly solid (solid area≥80%)
- Ultrasound imaging of target nodule assessed by 2017 ACR TI-RADS(≤Grade 3), and proved benign by once FNA (bethesda categoryⅡ); Ultrasound imaging of target nodule assessed by 2017 ACR TI-RADS( Grade 4), and proved benign by twice FNA (bethesda categoryⅡ).
- The distance from the posterior edge of the target nodule to the skin is not less than 12.3mm, and the depth from the anterior edge of the target nodule to the skin is not more than 19.4mm.
- No macro-calcifications in target nodule, macro-calcifications induce a significant shadow in the ultrsound imaging.
- the skin is free from any significant thick scars.
- If there are more than one nodule on the treatment side, all of the following conditions shall be met:
- No more than 2 nodules except the target nodule.
- Maximum diameter of the nodules is smaller than 1 cm and ultrasound imaging ≤ Grade 3 assessed by 2017 ACR TI-RADS.
- If there are nodules on the opposite side of HIFU treatment side, one of the following conditions shall be met:
- Maximum diameter of these nodules is smaller than 1 cm and ultrasound imaging ≤ Grade 3 assessed by 2017 ACR TI-RADS.
- Only one nodule with 1cm≤ max diameter < 2cm, or/and no more than three nodule with max diameter <1cm. Ultrasonic images of all nodules≤Grade 3 assessed by 2017 ACR TI-RADS.
- Absence of abnormal vocal cord mobility at laryngoscopy.
- Patients reject or cannot tolerate invasive surgical treatment.
- Patient has signed a written informed consent.
Who cannot join
- The ultrasound report indicated that follicular tumors were not excluded.
- Known history of thyroid cancer or other neoplasias in the neck region.
- Head and/or neck disease that prevents hyper-extension of neck.
- Patients currently in the acute phase of any disease.
- History of head and neck, pulmonary and systemic infections in the last 2 weeks.
- The white blood cell test result exceeded the upper limit of the normal range.
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- Tenderness of the thyroid and/or thyroid nodules.
- History of arrhythmia, coronary heart disease or valvular heart disease, heart failure.
- The blood pressure is not controlled after the combination of three antihypertensive drugs (SBP ≥ 140 mmHg, DBP ≥ 90 mmHg)
- COPD history or acute phase of asthma attach
- Patients with liver dysfunction ( ALT or AST level 2.5 times higher than the upper limit of the normal reference range)
- Patients with renal insufficiency( eGFR< 45ml/min/1.73m2).
- Fasting blood glucose >8mmol/L after hypoglycemic drug treatment
- Patients currently sufferrign from hematological diseases or bleeding tendency, or patients currently requiring continuous administration of antiplatelet and anticoagulant drugs
- Pregnant or lactating woman
- Woman who Plan to be pregnant during the study period.
- Any contraindication to the assigned analgesia/ anaesthesia.
- Patients who participated in other clinical trials in the past 3 months.
- Alzhemier's patients or patient with cognitive impairment.
- Other patients judged by the investigators to be unsuitable for the clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Randomized, Controlled Trial of High Intensity Focused Ultrasound (HIFU) Treatment of Benign Thyroid Nodules
This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules.
Read the detailed description
This clinical trial is a prospective, multicentre, randomized, controlled study of high intensity focused ultrasound (HIFU) treatment of benign thyroid nodules. this study will include 240 patients with benign thyroid nodules that meet all ths the inclusion / exclusion criteria and will be randomly divided into two groups at 1: 1 ratio. Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms assessed by VAS score.
- Conditions
- Thyroid Nodule (Benign)
- Being tested
- Device: Echopulse (HIFU ablation)
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Echopulse (HIFU ablation)Device
High-intensity focused ultrasound (HIFU) is a non-invasive, non-invasive treatment method. The principle is to focus high-intensity ultrasound on the target area. Energy is absorbed by the target tissue and converted into thermal energy. The local temperature quickly reaches a maximum of 85 ° C. It induces coagulative necrosis of focus tissue cells, but does not damage the tissues surrounding the treatment targ
| Study group | Role | What they receive |
|---|---|---|
| Test group HIFU treatment | Experimental | Patients in the test group (120) will be treated with high intensity focused ultrasound (HIFU). The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms (VAS score). Receives: Device: Device: Echopulse (HIFU ablation) |
| Control group | No intervention | Patients in the control group (120) will be actively observed and followed up. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms (VAS score). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness evaluation using treatment effective rate
percentage of patients who achieve treatment success (volume reduction ratio > 50%) at 12 months after HIFU treatment assessed by ultrasound examination
Measured: 12 Months
Secondary outcomes (2)
Symptoms score improvement
Using Visual Analogic Scale between (0-100 mm) to evaluate the improvement of appearance symptoms, compression symptoms and swallowing symptoms and pain.
With 0 being no pain and 100 being the worst pain imaginable
Measured: 12 Months
Incidence of Treatment-Emergent Adverse Events
Incidence of local and/or general adverse reactions and other related symptoms at 1, 7 days and 1, 3, 6 and 12 months follow-up after treatment
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startAug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule (Benign)Studies 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
- Model description
- Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. during the follow-up period, the follow-up visits time and follow-up examination items (clinical examination, ultrasonic examination and laboratory examination etc.) were the same in the both groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Kuang, MD, Principal investigator, Guangdong Province People's Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233398
- Sponsor's protocol ID
- HIFU20190725
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2020
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled Trial of High Intensity Focused Ultrasound (HIFU) Treatment of Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT04233398
- Acronym / sponsor ID
- HIFU20190725
- Conditions
- Thyroid Nodule (Benign)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Jan 2020 (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.
This clinical trial is to evaluate the effectiveness and the safety of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules.
Detailed description
This clinical trial is a prospective, multicentre, randomized, controlled study of high intensity focused ultrasound (HIFU) treatment of benign thyroid nodules. this study will include 240 patients with benign thyroid nodules that meet all ths the inclusion / exclusion criteria and will be randomly divided into two groups at 1: 1 ratio. Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms assessed by VAS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the test group will be treated with high intensity focused ultrasound (HIFU), while patients in the control group will be actively observed and followed up by ultrasound examination. during the follow-up period, the follow-up visits time and follow-up examination items (clinical examination, ultrasonic examination and laboratory examination etc.) were the same in the both groups
| Arm | Type | Receives |
|---|---|---|
| Test group HIFU treatment | Experimental | Device: Device: Echopulse (HIFU ablation)Patients in the test group (120) will be treated with high intensity focused ultrasound (HIFU). The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms (VAS score). |
| Control group | No intervention | –Patients in the control group (120) will be actively observed and followed up. The primary objective of this clinical trial is to evaluate the efficacy of the test device in the treatment of benign thyroid nodules, and the secondary objective is to evaluate the safety of the test device in the treatment of benign thyroid nodules and the improvement of symptoms (VAS score). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female patients older than 18 years and younger than 70 years
- No history of neck irradiation
- Normal thyroid function, serum calcitonin level, PTH and serum calcium at screening visit examination.
- No abnormal cervical lymph nodes during screening visit examination.
- The target thyroid nodule must meet all of the following conditions:
Key exclusion criteria (20 listed)
- The ultrasound report indicated that follicular tumors were not excluded.
- Known history of thyroid cancer or other neoplasias in the neck region.
- Head and/or neck disease that prevents hyper-extension of neck.
- Patients currently in the acute phase of any disease.
- History of head and neck, pulmonary and systemic infections in the last 2 weeks.
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 |
|---|---|---|
| Device: Echopulse (HIFU ablation)High-intensity focused ultrasound (HIFU) is a non-invasive, non-invasive treatment method. The principle is to focus high-intensity ultrasound on the target area. Energy is absorbed by the target tissue and converted into thermal energy. The local temperature quickly reaches a maximum of 85 ° C. It induces coagulative necrosis of focus tissue cells, but does not damage the tissues surrounding the treatment targ | Device | Test group HIFU treatment |
Primary outcome
Effectiveness evaluation using treatment effective rate
Time frame: 12 Months
percentage of patients who achieve treatment success (volume reduction ratio > 50%) at 12 months after HIFU treatment assessed by ultrasound examination
2 secondary outcomes
Symptoms score improvement
Time frame: 12 Months
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- 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.
Jian Kuang, MD principal investigator
Guangdong Province People's Hopital
Questions about this trial
What is this clinical trial studying?
A study testing Device: Echopulse (HIFU ablation) in people with Thyroid Nodule (Benign), run by Theraclion.
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 21 inclusion and 20 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yao Zhong, Master (+860755-21659096, joanna.zhong@theraclion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness evaluation using treatment effective rate (time frame: 12 Months). 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 11 Apr 2024.