Clinical Evaluation of Linear Z for Body Contouring

NCT07802431 | Recruiting

• 1 other identifier: LIN-BD-01-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Invasive Body Contouring

Keywords

Body contouring; High-Intensity Focused Ultrasound; HIFU; Localized Adiposity; Non-invasive Body Contouring; Fat Reduction

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Circumference of the Target Area at Day 90

  The change in circumference of the treated target area from baseline to Day 90 will be assessed using standardized circumference measurements. The target area includes the lower abdomen and bilateral flanks. Circumference will be measured at a predefined and documented anatomical level using a standardized procedure, and the average of three consecutive measurements will be used for analysis.

  Baseline to day 90

Secondary Outcomes (10)

• Change From Baseline in Circumference of the Target Area at Day 30

  Baseline to Day 30

• Proportion of Participants Achieving ≥5 cm Reduction in Circumference at Day 90

  Baseline to Day 90

• Proportion of Participants Achieving ≥10 cm Reduction in Circumference at Day 90

  Baseline to day 90

• Global Aesthetic Improvement Scale (GAIS) Score

  Day 30 and Day 90

• Blinded Independent Photographic Evaluation of Aesthetic Improvement

  Baseline, Day 30 and Day 90

Other Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events

  From treatment through Day 90

Study Arms (1)

A single-arm study where subjects will receive HIFU for non invasive body contouring

EXPERIMENTAL

Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks. Treatment will be performed according to the predefined study treatment parameters. Participants will be followed for approximately 90 days after treatment to evaluate the safety and effectiveness of the treatment.

Device: High Intensity Focused Ultrasound

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.

A single-arm study where subjects will receive HIFU for non invasive body contouring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeisys Medical Inc: lead

Study Sites (1)

Especialistas de la Piel y Cirugía, S.C.

Nuevo León, Monterrey, 64060, Mexico

RECRUITING

Central Study Contacts

Narendra Kumar, Dr., PhD

CONTACT

+65 9238 3614; narendrakumar@jeisys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)