NCT04223557

A Cholesterol Lowering Therapy of Focused Power Ultrasound Mediated Perirenal Fat Ablation

Non-invasive Focused Power Ultrasound Mediated Inferior Perirenal Fat Ablation for Lowering Serum Cholesterol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about focused power ultrasound (FPU)-mediated perirenal fat (PRF) ablation for lowering serum cholesterol levels. The main questions it aims to answer are: What is the efficacy, safety, and tolerability of focused power ultrasound (FPU)-mediated perirenal fat ablation for lowering low-density lipoprotein cholesterol (LDL-C) levels? Participants will randomly receive PRF ablation or sham treatment, and undergo follow-up at 24 hours, 1 month, and 3 months post-procedure.

Detailed description

This study aims to evaluate and validate the efficacy and safety of the therapeutic approach of PRF ablation-executed by an externally delivered, completely non-invasive FPU-on serum cholesterol levels in patients with dyslipidaemia, with a low-to-moderate 10-year overall risk of ASCVD. This is an investigator-initiated, single site, randomised, double-blinded, sham-controlled clinical trial. Further eligibility assessment will be performed at the secondary screening, which has the same design as the baseline examination. Subjects taking lipid-lowering drugs before the recruitment are permitted to enter the secondary screening after a 4-week washout period, to allow for sufficient elimination. Eighty-four eligible participants will be randomly assigned to either the FPU treatment group or the sham-treatment group, at a ratio of 2:1.

Conditions

• Visceral Obesity
• Ultrasound Therapy
• Dyslipidemias

Interventions

Type	Name	Description
DEVICE	focused power ultrasound treatment	Patients will be placed in the lateral decubitus position and receive treatment with sequential bilateral PRF ablation. Before the treatment, a professional sonographer will be responsible for the length, thickness, and width of PRF sac measurement and localisation, and utilise the ultrasonic diagnostic transducer to delineate the targeted region. The treatment will launch layer-by-layer. After confirming accurate localization of the treatment, layer-by-layer PRF ablation will be performed on the patients. The device generates and delivers a pattern of conic-shaped ultrasound energy to the PRF sac noninvasively. The treatment of FPU-mediated PRF ablation will be implemented once.
DEVICE	Sham treatment	Participants will receive the same procedure as those in the FPU treatment including PRF ultrasonic measurement and localization and focused ultrasound treatment parameters setting, except that no energy will be delivered to the PRF.

Timeline

• Start date: 2020-05-30
• Primary completion: 2021-07-08
• Completion: 2021-12-31
• First posted: 2020-01-10
• Last updated: 2023-07-06

Locations

1 site across 1 country: China