Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT06877234
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）
Sponsor:
Shenzhen Pulsecare Medical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ModulationHTN1
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: