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

NCT04223557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-07-06

No results posted yet for this study

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.

Conditions

  • Visceral Obesity
  • Ultrasound Therapy
  • Dyslipidemias

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Xiangqing Kong, M.D.&PhD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-30
Primary Completion
2021-07-08
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223557 on ClinicalTrials.gov