An interventional study of High Intensity Focused Ultrasound in Non Invasive Body Contouring, sponsored by Jeisys Medical Inc. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Jeisys Medical Inc · Not applicable, Interventional, and Treatment
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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.
Jeisys Medical Inc is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: Baseline to day 90
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after each treatment.
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be monitored from the treatment procedure through the final follow-up visit. Adverse events will be assessed for severity and relationship to the study device/procedure in accordance with the study protocol.
Time frame: From treatment through Day 90
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
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