RECRUITING Not applicable ClinicalTrials.gov

Clinical Evaluation of Linear Z for Body Contouring

Sponsor: Jeisys Medical Inc • ClinicalTrials.gov ID: NCT07802431

Registry updated: 2026-09-03

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

High Intensity Focused Ultrasound (Device)
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks. The device delivers focused ultrasound energy at specific depths within the subcutaneous tissue. Treatment will be performed according to the sponsor-approved treatment manual, site-specific operating procedures, and study procedures. All participants will receive treatment to both the lower abdomen and flanks during the treatment session and will be followed for approximately 90 days after treatment.

Eligibility 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.

Conditions

Non Invasive Body Contouring

Locations

Especialistas de la Piel y Cirugía, S.C. — Nuevo León, Monterrey, Mexico

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment