Lower abdomen and flank body contouring with LinearZ
Official title: Prospective, Single-center, Single-arm Clinical Research Evaluating the Safety and Effectiveness of Linear Z for Non-invasive Body Contouring of the Abdomen and Flanks
Run by Jeisys Medical Inc · NCT07802431 · Data updated 2026-11-12
This study tests whether a non-invasive focused ultrasound device called LinearZ can reduce the circumference of the lower belly and love handles in adults after a single treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Jeisys Medical Inc Industry-sponsored |
| Locations | 1 site (Nuevo León, Monterrey) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | December 20, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07802431 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with localized, visible subcutaneous adiposity of the abdomen and flanks, BMI >20 kg/m², and adequate fat thickness who are stable in weight and willing to maintain consistent habits.
✕Probably not a fit
Individuals with insufficient fat thickness, skin laxity issues, recent body contouring, or conditions that interfere with treatment may not see benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm study evaluating the safety and effectiveness of LinearZ, a non-invasive focused ultrasound device, for contouring the lower abdomen and flanks. Approximately 30 adults with measurable subcutaneous fat will receive one treatment and be followed for about 90 days. Primary outcome is change in treated area circumference at 90 days, with additional assessments including circumference at 30 days, aesthetic improvement, satisfaction, weight, BMI, body composition, and imaging analyses. Safety will be monitored throughout the study. No control group or randomization is used, and results will be based on standardized measurements and imaging.
Why it matters
Potential benefit: If successful, participants may experience reduced abdominal and flank fat and improved contour without surgery.
How similar studies have gone: Previous non-invasive HIFU/body contouring studies have shown variable but promising reductions in circumference and contour improvements with similar approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Especialistas de la Piel y Cirugía, S.C.
Nuevo León, Monterrey, Mexico Recruiting
Study contacts
- Study coordinator: Narendra Kumar, Dr., PhD
- Email: narendrakumar@jeisys.com
- Phone: +65 9238 3614
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.