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

Dyslipidemias Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity, Abdominal
• Ultrasound Therapy
• Visceral Obesity

• NCT number: NCT04223557
• Study type: Interventional
• Source: The First Affiliated Hospital with Nanjing Medical University
• Status: Completed
• Phase: N/A
• Start date: May 30, 2020
• Completion date: December 31, 2021