Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)
NCT06018493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2026-02-27
Summary
This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
Conditions
- Hypertension
- Blood Pressure
- Cardiovascular Diseases
Interventions
- DEVICE
-
focused power ultrasound mediate inferior perirenal adipose tissue modification
This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.
- DEVICE
-
sham-control group
participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.
Sponsors & Collaborators
-
The Affiliated Jiangning Hospital of Nanjing Medical University
collaborator OTHER -
Suzhou Municipal Hospital
collaborator OTHER -
The First People's Hospital of Changzhou
collaborator OTHER -
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2025-02-12
- Completion
- 2025-04-20
Countries
- China
Study Locations
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