A Cholesterol Lowering Therapy of Focused Power Ultrasound Mediated Perirenal Fat Ablation
Condition: Visceral Obesity; Ultrasound Therapy; Dyslipidemias
MeSH terms: Dyslipidemias; Obesity, Abdominal
Study type: Interventional

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.
    

Intervention name(s): focused power ultrasound treatment; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blinded, sham-controlled study.The ratio of the treatment group versus sham-control group was 2:1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perirenal fat; Ultrasound Therapy; Dyslipidemias; low-density lipoprotein cholesterol