None listed
Conditions
Interventions
Medical Device : [ Liposci procedure ]
? Prepare laser investigation by inserting a fiber of liposci, a liposcoi laser surgical instrument, into Cannula.
? Use a laser light wave at the same time as 1
s fat level, and set the total abdominal treatment time to not exceed 60 minutes.
? Terminate the treatment when Manual promotion confirms that the softness and thinness of the soft tissue in the tre
Sponsors
WONTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female over 19 years of age. 2. BMI (Body mass index) = 35 kg/m2 3. If the thickness of the lower abdomen fat measured using Caliper is greater than 2.5 cm. 4. No other treatment is planned for body contouring or weight loss during this clinical trial. 5. If you agree to keep your weight (within ± 5%) by not changing your diet or lifestyle 6. Voluntarily decided to participate in this clinical trial and gave written consent
Exclusion criteria
Exclusion criteria: 1. pregnant, nursing, or women planning to conceive within the clinical trial period or who do not agree to the proper use of contraceptives during the clinical trial period. 2. In case of history or related treatment of blood clotting disorder (anti-platelet, anticoagulant, thrombotic release, aspirin, anti-inflammatory drugs) 3. If you have experience with esthetic treatment in the treatment area within 12 months prior to the screening, or with surgical treatment to remove abdominal fat (fat-absorbent, laparotomy, mezzoterapi, etc.) 4. In case there are implanted electrical devices such as pacemaker and defibrillator. 5. Unregulated diabetes or cardiovascular disease 6. For LDL cholesterol = 190 mg/dL 7. Patient is diagnosed with hepatitis and is in treatment 3 or within 12 months of the end of hepatitis treatment 8. Surgical operation on the surgical site within 18 months of screening 9. If there is a history of skin cancer or pre-cancerous lesions in the treatment area 10. In case there is a skin condition, such as infection, injury, and scarring, in the area of treatment 11. In case of abdominal dislocation. 12. If there is a keloid or hyperplastic scar in the treatment area 13. If you have a history of light hypersensitivity. 14. If you have experience with immunosuppression or have HIV infection, autoimmune diseases with AIDS, or people who take antipsychotic drugs, 15. Neuropathy, skin irritation, and diabetic neuropathy 16. Participating in clinical trials of medicines or medical devices within one month of screening. However, it is possible to register if it does not affect this clinical trial assessment at the discretion of the tester 17. Other cases where the tester determines that they are not suitable for this clinical trial or may increase the risk associated with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Variation of abdominal perimeter (cm) and rate of change (%);Safety: Ideal Case, Vital signs, Laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Variation in thickness of abdominal subcutaneous fat (mm) and rate of change (%) measured by ultrasonic waves | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Park
Soon Chun Hyang University Hospital Bucheon
Outcome results
None listed