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

Completed · Not applicable

Conditions studied: Abdominal Subcutaneous Fat

In brief

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.

Key facts

Study ID

NCT04206384

Run by

CAO Group, Inc.

People needed

52

Starts

2019-12-02

Expected to finish

2020-05-12

Last updated by the study team

2021-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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