Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

Abdominal Subcutaneous Fat Clinical Trial

Official title: Efficacy of Low-Frequency, High-Intensity Ultrasound for Reduction in Subdermal Adipose Layers

Status Completed

Clinical Trial Summary

This study evaluates the effectiveness and safety of externally applied lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of fat cells/tissues below the skin, evidenced by a reduction in patient waist circumference.

Clinical Trial Description

This study is to evaluate principally the effectiveness, and secondarily the safety, of external application of lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of adipose cells/tissues in the subcutaneous region. The application of higher frequency (200kHz to 3MHz) ultrasound for this purpose has previously been demonstrated and such devices have received clearance for treatment in the United States. The question remains whether application of ultrasound at a lower frequency (35kHz to 45kHz) can achieve comparable results without introducing any new or elevated risks to the patient. This study will apply 3 treatments of the ultrasound energy and evaluate the change in patient's waist circumference, which would be evidence of reducing sub-cutaneous adipose cells/tissues. ;

Related Conditions & MeSH terms

• Abdominal Subcutaneous Fat

• NCT number: NCT04206384
• Study type: Interventional
• Source: CAO Group, Inc.
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Completion date: May 12, 2020