Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM） (ModulationHTN1)

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.

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Procedure: Ultrasonic Nerve Ablation System

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingfeng J wang, Postdoctoral fellow; Phone Number: 02081332199; Email: wangjingfeng2017@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
      • Contact: Wang Jing Feng, professor; Phone Number: 0086-020-81332199

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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;

Exclusion Criteria:

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:

a. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exploratory Clinical Study of the Ultrasound Nerve Ablation System	Procedure: Ultrasonic Nerve Ablation System; Treatment of patients with essential hypertension using the ultrasonic nerve ablation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Within 30 days after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	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	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	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%).	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	1 month, 2 months, 3 months, 6 months after the operation
The incidence rate of device defects.	The number of occurrences of device defects	during the operation

Collaborators and Investigators

• Sponsor: Shenzhen Pulsecare Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension
• Other Study ID Numbers: MW-2301-T-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No