Efficacy of Low-Frequency, High-Intensity Ultrasound for Reduction in Subdermal Adipose Layers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Abdominal Subcutaneous Fat
- Sponsor
- CAO Group, Inc.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Waist Circumference Change
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age equal to or above 18
- •Body Mass Index ≥ 25.
Exclusion Criteria
- •Age equal to or below
- •Body Mass Index \<
- •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.
Outcomes
Primary Outcomes
Waist Circumference Change
Time Frame: 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).
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).
Secondary Outcomes
- Number of Participants With Pain(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.)