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

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.

NCT Number	NCT06877234
Lead Sponsor	Shenzhen Pulsecare Medical Technology Co., Ltd.
Conditions	Essential Hypertension
Enrollment	6 participants
Start Date	2024-08-08
Primary Completion	2025-12 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-06-19