CompletedNot Applicable

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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

Trial details

NCT IDNCT04206384

SponsorCAO Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-01

Results submitted2020-11-06

View on ClinicalTrials.gov More Abdominal Subcutaneous Fat trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.