Efficacy and Safety of laser surgery 'Liposci' procedure in initial validity reduction of abdominal circumference : A Single-blind Randomized Clinical Trial
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0004384
- Lead Sponsor
- WONTECH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Variation of abdominal perimeter (cm) and rate of change (%);Safety: Ideal Case, Vital signs, Laboratory test
- Secondary Outcome Measures
Name Time Method Efficacy: Variation in thickness of abdominal subcutaneous fat (mm) and rate of change (%) measured by ultrasonic waves