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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Males and Females aged 18-70 years old.

• Each side of caudal perirenal fat volume \>8000mm3(measured by ultrasound).

• Low and medium-risk of arteriosclerotic cardiovascular disease (ASCVD) with 3.4 ≤ LDL-C \< 4.9 mmol/L or 5.2 ≤ TC \< 7.2 mmol/L, as defined by the Chinese guidelines for the management of dyslipidemia in adults(revised edition 2016).

• Participants should be willing to sign the informed consent form of the study.

Locations
Other Locations
China
JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University
Nanjing
Time Frame
Start Date: 2020-05-30
Completion Date: 2021-12-31
Participants
Target number of participants: 84
Treatments
Experimental: FPU treatment
Transcutaneous non-invasive ultrasound will be administered to the peri-renal fat for one time via a focused power ultrasound system (FPU) device.
Sham_comparator: Sham treatment
Partcipates will receive the same procedure as those in experimental arm except that the device will not be activated.
Authors
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov