None listed
Conditions
Interventions
Medical Device : This study is a single-center, single-arm, exploratory clinical trial designed to evaluate the efficacy and safety of the focused ultrasound stimulation system LIPOGE-X (ULTLINE, ESK-
no comparator or control group is included.
At Visit 2 (Baseline, Day 0), the investigational medical device is applied to the abdomen using the Fit X2-9 cartridge with a focal depth of 9 mm. After a
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females aged 19 years or older who wish to reduce abdominal circumference 2) Body Mass Index (BMI) = 30 kg/m² 3) Individuals with abdominal fat thickness of = 2.5 cm as measured by caliper 4) Individuals who have no plans to receive other treatments for body contouring or weight loss during the clinical trial period 5) Individuals who agree to maintain their body weight (within ±5 kg) by not changing their diet or lifestyle 6) Individuals who are able to communicate effectively with the investigator, understand the clinical trial, and voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant, breastfeeding, planning to become pregnant during the study period, or unwilling to use appropriate contraception during the study 2) Individuals with a history of bleeding disorders or those currently receiving or planning to receive related treatments (antiplatelet agents, anticoagulants, thrombolytics, aspirin, anti-inflammatory drugs) 3) Individuals who have received aesthetic treatments or surgical procedures (e.g., liposuction, abdominoplasty, mesotherapy) in the treatment area within 12 months prior to screening 4) Individuals with implanted electrical devices such as pacemakers or defibrillators 5) Individuals with uncontrolled diabetes or cardiovascular disease 6) Individuals with LDL cholesterol = 190 mg/dL 7) Individuals currently undergoing treatment for hepatitis or within 12 months after completing treatment 8) Individuals who have undergone surgery in the treatment area within 18 months prior to screening 9) Individuals with a history of skin cancer or precancerous lesions in the treatment area 10) Individuals with infections, wounds, scars, or other skin conditions in the treatment area 11) Individuals with abdominal hernia 12) Individuals with keloid or hypertrophic scars in the treatment area 13) Individuals with a history of immunosuppression, autoimmune diseases including HIV/AIDS, or who are taking immunosuppressive medications 14) Individuals with disorders of the cardiovascular, gastrointestinal, respiratory, endocrine, central nervous systems, skin sensation, or diabetic neuropathy 15) Individuals who have participated in another clinical trial involving drugs or medical devices within 1 month prior to screening, unless deemed not to interfere with this study by the investigator 16) Any other individuals deemed unsuitable for participation or at increased risk by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in abdominal circumference at Week 12 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in abdominal circumference at Weeks 1 and 4 compared to baseline;Occurrence and frequency of adverse events and serious adverse events;Evaluation of local skin reactions (erythema, edema, pain, etc.) and post-treatment discomfort (VAS) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Joon Park
Ajou University Hospital
Outcome results
None listed