Essential HypertensionModulationHTN1NCT06877234
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）
A study testing Ultrasonic Nerve Ablation System in people with Essential Hypertension, run by Shenzhen Pulsecare Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 subjects are planned to be included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Ultrasonic Nerve Ablation System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2024to Mar 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;
Who cannot join
- Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;
- Preoperative exclusion criteria based on CTA imaging:
- Visual inspection shows that the diameter stenosis of the renal artery on either side > 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
Guangzhou, Guangdong, 510120
Wang Jing Feng, professor, 0086-020-81332199
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension
This study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 subjects are planned to be included. After the subjects sign the informed consent form (ICF) approved by the ethics committee, they will enter the screening procedure. Subjects who meet the inclusion criteria and do not meet any of the clinical exclusion criteria will be enrolled after undergoing renal artery CTA angiography.
All patients will undergo clinical evaluation and blood pressure measurement during the operation, at the time of discharge, and at 1 month, 2 months, 3 months, and 6 months after the operation.
It is recommended that the anti-hypertensive medications used before the operation should not be changed within 6 months after the operation for the cases. When the systolic blood pressure (SBP) is ≥ 180 mmHg or there are clinical symptoms caused by hypertension, the drug dosage should be increased as a priority, and then the anti-hypertensive medications should be adjusted. When the systolic blood pressure (SBP) is ≤ 120 mmHg or there are clinical symptoms caused by a decrease in blood pressure, the anti-hypertensive medications should be reduced.
- Conditions
- Essential Hypertension
- Being tested
- Ultrasonic Nerve Ablation System
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Nerve Ablation SystemProcedure or surgery
Treatment of patients with essential hypertension using the ultrasonic nerve ablation system
| Study group | Role | What they receive |
|---|---|---|
| Exploratory Clinical Study of the Ultrasound Nerve Ablation System | Experimental | Not described Receives: Procedure: Ultrasonic Nerve Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the average daytime systolic blood pressure two months after the operation
That is, the difference between the average daytime (from 7:00 to 22:00) systolic blood pressure measured before the operation and the average daytime systolic blood pressure measured during the follow-up visit two months after the operation
Measured: Two months after the operation
Major adverse events within 30 days after the operation
Major adverse events include: all-cause mortality, renal complications, renal artery embolism events, complications of interventional treatment, hypertensive/hypotensive crises during hospitalization, and major cardiovascular and cerebrovascular complications.
Measured: Within 30 days after the operation
Secondary outcomes (11)
The changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation
Changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation (1 month, 3 months, 6 months) That is, the difference between the average systolic blood pressure of ambulatory blood pressure measured during the daytime (7:00-22:00), at night (22:00-7:00) and over 24 hours before the operation and the average systolic blood pressure of ambulatory blood pressure measured during the daytime, at night and over 24 hours during the postoperative follow-up.
Measured: 1 month, 3 months, 6 months after the operation
Changes in the average diastolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation
That is, the difference between the average diastolic blood pressure of ambulatory blood pressure measured during the daytime (7:00-22:00), at night (22:00-7:00) and over 24 hours before the operation, and the average diastolic blood pressure of ambulatory blood pressure measured during the daytime, at night and over 24 hours during the postoperative follow-up
Measured: 1 month, 2 months, 3 months, 6 months after the operation
The attainment rate of systolic blood pressure reaching the standard in the outpatient clinic after the operation
That is, the proportion of subjects whose systolic blood pressure measured in the outpatient clinic during the postoperative follow-up is less than 140 mmHg.
Measured: 1 month, 2 months, 3 months, 6 months after the operation
The change in systolic blood pressure measured in the outpatient clinic after the operation
That is, the difference between the systolic blood pressure measured in the outpatient clinic before the operation and the systolic blood pressure measured in the outpatient clinic during the postoperative follow-up
Measured: 1 month, 2 months, 3 months, 6 months after the operation
The average number of types of medications taken after the operation
The change in the average number of types of medications taken during the postoperative follow-up period, compared with the antihypertensive medications taken before the operation.
Measured: 1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of complications of interventional treatment
It refers to the intraoperative or postoperative related complications that occur after the research device has completed the renal artery ultrasound ablation surgery, such as renal artery perforation, renal artery dissection, acute infection, etc
Measured: 1 month, 2 months, 3 months, 6 months after the operation
All-cause mortality rate
Death caused by any reason as informed during the clinical follow-up
Measured: 1 month, 2 months, 3 months, 6 months after the operation
Cardiovascular and cerebrovascular complications
It refers to myocardial infarction, any stroke event (including intracerebral hemorrhage and cerebral infarction), and any coronary revascularization
Measured: 1 month, 2 months, 3 months, 6 months after the operation
Renal complications
Refers to eGFR <15 mL/min/1.73㎡, requirement for renal replacement therapy, or renal artery revascularization; renal artery stenosis (refers to diameter stenosis ≥50%).
Measured: 1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of adverse events and serious adverse events
The number of adverse events and serious adverse events
Measured: 1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of device defects.
The number of occurrences of device defects
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start8 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877234
- Sponsor's protocol ID
- MW-2301-T-01
- Acronym
- ModulationHTN1
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension
- ClinicalTrials.gov ID
- NCT06877234
- Acronym / sponsor ID
- ModulationHTN1 / MW-2301-T-01
- Conditions
- Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Mar 2025 (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 study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 subjects are planned to be included. After the subjects sign the informed consent form (ICF) approved by the ethics committee, they will enter the screening procedure. Subjects who meet the inclusion criteria and do not meet any of the clinical exclusion criteria will be enrolled after undergoing renal artery CTA angiography.
All patients will undergo clinical evaluation and blood pressure measurement during the operation, at the time of discharge, and at 1 month, 2 months, 3 months, and 6 months after the operation.
It is recommended that the anti-hypertensive medications used before the operation should not be changed within 6 months after the operation for the cases. When the systolic blood pressure (SBP) is ≥ 180 mmHg or there are clinical symptoms caused by hypertension, the drug dosage should be increased as a priority, and then the anti-hypertensive medications should be adjusted. When the systolic blood pressure (SBP) is ≤ 120 mmHg or there are clinical symptoms caused by a decrease in blood pressure, the anti-hypertensive medications should be reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploratory Clinical Study of the Ultrasound Nerve Ablation System | Experimental | Procedure: Ultrasonic Nerve Ablation System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;
Key exclusion criteria (3 listed)
- Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;
- Visual inspection shows that the diameter stenosis of the renal artery on either side > 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.
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 |
|---|---|---|
| Ultrasonic Nerve Ablation SystemTreatment of patients with essential hypertension using the ultrasonic nerve ablation system | Procedure or surgery | Exploratory Clinical Study of the Ultrasound Nerve Ablation System |
Primary outcome
The change in the average daytime systolic blood pressure two months after the operation
Time frame: Two months after the operation
That is, the difference between the average daytime (from 7:00 to 22:00) systolic blood pressure measured before the operation and the average daytime systolic blood pressure measured during the follow-up visit two months after the operation
Major adverse events within 30 days after the operation
Time frame: Within 30 days after the operation
Major adverse events include: all-cause mortality, renal complications, renal artery embolism events, complications of interventional treatment, hypertensive/hypotensive crises during hospitalization, and major cardiovascular and cerebrovascular complications.
11 secondary outcomes
The changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation
Time frame: 1 month, 3 months, 6 months after the operation
Changes in the average diastolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
The attainment rate of systolic blood pressure reaching the standard in the outpatient clinic after the operation
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
The change in systolic blood pressure measured in the outpatient clinic after the operation
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
The average number of types of medications taken after the operation
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of complications of interventional treatment
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
All-cause mortality rate
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
Cardiovascular and cerebrovascular complications
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
Renal complications
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of adverse events and serious adverse events
Time frame: 1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of device defects.
Time frame: during the 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 19 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Nerve Ablation System in people with Essential Hypertension, run by Shenzhen Pulsecare Medical Technology Co., Ltd. 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 1 inclusion and 3 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 19 Jun 2025. 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?
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 Jingfeng J wang, Postdoctoral fellow (02081332199, wangjingfeng2017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the average daytime systolic blood pressure two months after the operation (time frame: Two months after the operation). 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 19 Jun 2025.