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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Subcutaneous Fat
• Intervention / Treatment: Device: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Midvale, Utah, United States, 84047
      • Just the Right Cruves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age equal to or above 18
• Body Mass Index ≥ 25.

Exclusion Criteria:

• Age equal to or below 17.
• Body Mass Index < 25.
• Open sores, wounds, or otherwise compromised skin in the treatment area
• History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing.
• Known or suspected pregnancy, or active nursing.
• General systemic conditions of arteriosclerosis, anemia, aortic aneurysm, or hypertension.
• Liver conditions such as hyperlipidemia, hepatitis, liver disease, or abnormal liver function.
• Diabetes or blood-glucose sensitivity
• Any prior invasive cosmetic surgery to the waist or abdominal area, such as liposuction.
• Hernias or diastasis recti within the treatment area.
• Concurrent, or within the last 6 months, participation in any clinical trial for another device or drug.
• Existing bacterial or viral infections (influenza, rhinovirus, hepatitis, pneumonia, tuberculosis, and the like)
• Presence of acne vulgaris, herpes zoster, psoriasis vulgaris, or similar skin conditions in the treatment area.
• Any type of cosmetic treatment to the target area within the last 6 months.
• Implanted active medical device anywhere in the subject, or metallic or polymeric implants in the vicinity of the treatment area.
• Currently undergoing, or recently underwent, chemotherapy or radiation treatment.
• Per the investigator's discretion, any physical or mental condition which may compromise the patient's safety or welfare.
• Failure to complete the study as outlined.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2.	Device: Ultrasound; Ultimate Contour Body Sculpting Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference Change	Change in measurable circumference of the patient's abdominal area from Baseline to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).	The difference between the circumference measurement immediately prior to the first treatment (Baseline) to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Pain	Incidence of pain during each application of the device and/or immediately following each application of the device (up to 15 minutes after use of the device ceased).	Assessed during and immediately after (up to 15 minutes after use ceased) each application of the device, and at 1 week, 4 weeks, and 12 weeks post-treatment.

Collaborators and Investigators

• Sponsor: CAO Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Low-Frequency
• Other Study ID Numbers: 005-00036-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes