RecruitingNot ApplicableNCT06877234

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

An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension


Sponsor

Shenzhen Pulsecare Medical Technology Co., Ltd.

Enrollment

6 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human safety study of a new ultrasound renal denervation device — targeting nerves near the kidneys to lower blood pressure — for people with treatment-resistant high blood pressure. **You may be eligible if...** - You are between 18 and 65 years old - You have essential hypertension (high blood pressure not caused by another medical condition) - You have been on 2 or more blood pressure medications at standard doses for at least 4 weeks - Your clinic blood pressure is still 150-180 mmHg (systolic) and 24-hour monitoring shows it is still above thresholds **You may NOT be eligible if...** - You have secondary causes of high blood pressure - You have significant kidney artery disease - You have had a recent heart attack, stroke, or heart failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREUltrasonic Nerve Ablation System

Treatment of patients with essential hypertension using the ultrasonic nerve ablation system


Locations(1)

the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital)

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06877234


Related Trials