Clinical Evaluation of Linear Z for Body Contouring
ConditionNon Invasive Body Contouring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJeisys Medical Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
High Intensity Focused Ultrasound
DeviceParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: A single-arm study where subjects will receive HIFU for non invasive body contouringExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to day 90Secondary outcomes
1
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 302
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 903
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 904
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 90Other outcomes
1
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 90Sponsors and contacts
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Source ClinicalTrials.gov