Clinical Evaluation of Linear Z for Body Contouring

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

This clinical study will evaluate the safety and effectiveness of LinearZ, a non-invasive focused ultrasound device, for body contouring of the lower abdomen and flanks.

Approximately 30 adults with localized fat in the abdomen and flanks will participate in the study. Each participant will receive one treatment with LinearZ to the lower abdomen and flanks and will be followed for approximately 90 days.

The main purpose of the study is to determine whether treatment with LinearZ reduces the circumference of the treated area 90 days after treatment. The study will also evaluate changes in body circumference at Day 30, changes in body contour and appearance, participant satisfaction, body weight, body mass index (BMI), and body composition. Standardized photographs and three-dimensional images will also be used to assess changes in the treated areas.

The safety and tolerability of the treatment will be evaluated throughout the study by monitoring adverse events and treatment-related pain or discomfort.

This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the safety and effectiveness of LinearZ for non-invasive body contouring of the lower abdomen and flanks.

Approximately 30 eligible adult participants with localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks will be enrolled. All eligible participants will receive a single treatment with LinearZ to the lower abdomen and bilateral flanks. There is no randomization or comparator group in this study.

LinearZ is a focused ultrasound device designed to deliver ultrasound energy at specific depths within subcutaneous tissue for non-invasive body contouring. Treatment will be performed according to predefined study procedures and sponsor-approved treatment instructions. Treatment parameters, including the treatment area, cartridge type, treatment depth, energy level, and number of treatment lines or shots, will be documented.

Participants will undergo screening and baseline assessments before treatment and will return for follow-up assessments approximately 30 and 90 days after treatment.

The primary effectiveness assessment is the change from baseline in the circumference of the treated area at Day 90. Circumference measurements will be performed using standardized procedures at predefined anatomical landmarks.

Additional effectiveness assessments include change in circumference at Day 30, aesthetic improvement, participant satisfaction, changes in body weight and body mass index (BMI), and changes in body composition. Standardized clinical photography and three-dimensional imaging will also be used to document and evaluate changes in body contour. Independent blinded evaluators will review standardized images to help minimize assessment bias.

Safety and tolerability will be evaluated throughout the study by monitoring treatment-emergent adverse events, device-related adverse events, serious adverse events, and treatment-related pain or discomfort. Immediate post-treatment skin reactions and other local responses will also be assessed.

Each participant will participate in the study for approximately 90 days from the day of treatment.

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.