NCT04206384

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: CAO Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Abdominal Subcutaneous Fat

Interventions

Type	Name	Description
DEVICE	Ultrasound	Ultimate Contour Body Sculpting Device

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-05-01
• Completion: 2020-05-12
• First posted: 2019-12-20
• Last updated: 2021-08-23
• Results posted: 2021-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study