KCT0004384尚未招募未知
Efficacy and Safety of laser surgery 'Liposci' procedure in initial validity reduction of abdominal circumference : A Single-blind Randomized Clinical Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- WONTECH
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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