Can sound waves sculpt the waistline without surgery?
NCT ID NCT07802431
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether a device called LinearZ, which uses focused ultrasound energy, can safely reduce fat in the lower abdomen and flanks. About 30 adults with localized fat will receive one treatment and be followed for 90 days. Researchers will measure changes in waist circumference, appearance, and satisfaction, while monitoring for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High Intensity Focused Ultrasound device (LinearZ)
- What this could lead to
- If it works, this could offer a non-invasive way to reduce belly and flank fat without surgery, with results lasting at least 90 days.
- What could go wrong
- This is a small, early study with only 30 participants, so results may not apply broadly. The treatment may cause pain or discomfort, and fat reduction could be modest or temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 18 to 65 years. * Participants of either sex. * Body mass index (BMI) greater than 20 kg/m². * Presence of localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks considered adequate for non-invasive body contouring by the investigator. * Minimum subcutaneous fat thickness of 30 mm, assessed clinically or by caliper/ultrasound. * Stable body weight (±3 kg) for the past 3 months. * Willingness to maintain stable diet and exercise habits during study participation. * Ability to comply with study requirements. * Provision of written informed consent. * Compliance with other clinical criteria defined for the study. Exclusion Criteria: * Pregnancy or breastfeeding. * Women planning pregnancy during study participation. * Previous body contouring procedures in the treatment area within the past 6 months. * Moderate to severe skin laxity in the treatment area that, in the investigator's judgment, is likely to interfere with assessment of body-contouring results. * Active dermatologic conditions or infections. * Implanted electronic devices, such as a pacemaker or implanted defibrillator. * Coagulation disorders. * Use of anticoagulant therapy. * Severe uncontrolled systemic disease. * Participation in another clinical investigation within the previous 30 days. * Any contraindication listed in the device manual. * Hernia in the treatment area. * Metal implants in the treatment area. * Significant open scars, tattoos, or wounds in the treatment area. * Altered sensation or neuropathy. * Active malignancy. * History of keloid formation or poor wound healing. * Use of weight-loss medications or GLP-1 agonists within the previous 3 months. * Previous liposuction or surgery in the treatment area within the previous 12 months. * Psychiatric conditions that affect the ability to provide informed consent or that affect body-image perception. * Women of childbearing potential who are unwilling to use medically acceptable contraception during study participation. * Any participant who, in the investigator's opinion, is not suitable for participation or is unlikely to comply with study procedures or complete the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Especialistas de la Piel y Cirugía, S.C.
RECRUITINGNuevo León, Monterrey, 64060, Mexico