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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Subcutaneous Fat

Intervention / Treatment
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* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Treatment Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* Ultimate Contour Body Sculpting Device<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Low-Frequency