Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction
United States52 participantsStarted 2019-12-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
* Failur…
What they're measuring
1
Waist Circumference Change
Timeframe: 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).