Non Invasive Body ContouringNCT07802431
Clinical Evaluation of Linear Z for Body Contouring
A study testing High Intensity Focused Ultrasound in people with Non Invasive Body Contouring, run by Jeisys Medical Inc at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Invasive Body Contouring
- What is being tested?
- High Intensity Focused Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Especialistas de la Piel y Cirugía, S.C.
Nuevo León, Monterrey, 64060
Hector Leal Leal, Dr., +528119655342, hleal@iderma.org
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Non Invasive Body Contouring
- Being tested
- High Intensity Focused Ultrasound
- Keywords
- Body contouring, High-Intensity Focused Ultrasound; HIFU, Localized Adiposity, Non-invasive Body Contouring, Fat Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to day 90
Secondary outcomes (10)
Change From Baseline in Circumference of the Target Area at Day 30
Change in circumference of the treated target area from baseline to Day 30 will be assessed using standardized circumference measurements at predefined anatomical points encompassing the lower abdomen and bilateral flanks. The average of three consecutive measurements will be used for analysis.
Measured: Baseline to Day 30
Proportion of Participants Achieving ≥5 cm Reduction in Circumference at Day 90
Percentage of participants who achieve a reduction of at least 5 cm in circumference of the treated target area compared with baseline.
Measured: Baseline to Day 90
Proportion of Participants Achieving ≥10 cm Reduction in Circumference at Day 90
Percentage of participants who achieve a reduction of at least 10 cm in circumference of the treated target area compared with baseline.
Measured: Baseline to day 90
Global Aesthetic Improvement Scale (GAIS) Score
Aesthetic improvement of the treated area will be assessed using the Global Aesthetic Improvement Scale (GAIS) at follow-up visits.
Measured: Day 30 and Day 90
Blinded Independent Photographic Evaluation of Aesthetic Improvement
Independent blinded evaluators will assess aesthetic improvement using standardized photographs obtained at baseline and follow-up visits.
Measured: Baseline, Day 30 and Day 90
Participant Satisfaction With Treatment Outcome
Participant satisfaction with the treatment outcome will be assessed using the study-specified satisfaction questionnaire.
Measured: Day 30 and Day 90
Change From Baseline in Body Weight
Change in participant body weight from baseline will be assessed at follow-up visits.
Measured: Baseline to Day 30 and Day 90
Change From Baseline in Body Mass Index (BMI)
Change in BMI from baseline will be assessed at follow-up visits. BMI is expressed in kg/m².
Measured: Baseline to Day 30 and Day 90
Change From Baseline in Fat Mass and Fat-Free Mass
Change in fat mass and fat-free mass from baseline will be assessed using the InBody body composition measurement system.
Measured: Baseline to Day 30 and Day 90
Procedural Pain and Discomfort Score Using an 11-Point Numeric Rating Scale
Procedural pain associated with radiofrequency treatment will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater procedural pain.
Measured: Immediately after each treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Invasive Body ContouringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeisys Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802431
- Sponsor's protocol ID
- LIN-BD-01-2026
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07802431
- Acronym / sponsor ID
- LIN-BD-01-2026
- Conditions
- Non Invasive Body Contouring
- Keywords
- Body contouring, High-Intensity Focused Ultrasound; HIFU, Localized Adiposity, Non-invasive Body Contouring, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jeisys Medical IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-arm study where subjects will receive HIFU for non invasive body contouring | Experimental | Device: High Intensity Focused UltrasoundParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused UltrasoundParticipants 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. | Device | A single-arm study where subjects will receive HIFU for non invasive body contouring |
Primary outcome
Change From Baseline in Circumference of the Target Area at Day 90
Time frame: Baseline to 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.
10 secondary outcomes
Change From Baseline in Circumference of the Target Area at Day 30
Time frame: Baseline to Day 30
Proportion of Participants Achieving ≥5 cm Reduction in Circumference at Day 90
Time frame: Baseline to Day 90
Proportion of Participants Achieving ≥10 cm Reduction in Circumference at Day 90
Time frame: Baseline to day 90
Global Aesthetic Improvement Scale (GAIS) Score
Time frame: Day 30 and Day 90
Blinded Independent Photographic Evaluation of Aesthetic Improvement
Time frame: Baseline, Day 30 and Day 90
Participant Satisfaction With Treatment Outcome
Time frame: Day 30 and Day 90
Change From Baseline in Body Weight
Time frame: Baseline to Day 30 and Day 90
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline to Day 30 and Day 90
Change From Baseline in Fat Mass and Fat-Free Mass
Time frame: Baseline to Day 30 and Day 90
Procedural Pain and Discomfort Score Using an 11-Point Numeric Rating Scale
Time frame: Immediately after each treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Focused Ultrasound in people with Non Invasive Body Contouring, run by Jeisys Medical Inc at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Narendra Kumar, Dr., PhD (+65 9238 3614, narendrakumar@jeisys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Circumference of the Target Area at Day 90 (time frame: Baseline to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.