Safety and Effectiveness of High Frequency Electrocautery for Abdominal Fat Reduction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Height of abdominal subcutaneous adipose tissue
研究概览
简要总结
The goal of this clinical trial is to learn if the intervention of radiofrequency technology can help treat abdominal fat hypertrophy and skin laxity in adults. The main questions it aims to answer are
- Does radiofrequency technology lower the abdominal subcutaneous adipose tissue height by ultrasound measurement?
- Does radiofrequency technology improve abdominal circumference data and lower the number of times participants need to use a rescue inhaler.
Researchers will compare the treatment side to the non-treatment side to see if radiofrequency technology works to treat abdominal fat hypertrophy and skin laxity?
Participants will:
- Accept the treatment of radiofrequency technology every week for 10 weeks.
- Visit the clinic 1 month and 3 months after the treatment ends for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the informed consent form;
- •Age 18 to 65 years old (including 18 and 65 years old), male or female;
- •The body mass index (BMI) is in the range of 22 ~ 35 (kg/m2) (including the cut-off value);
- •Maintain a stable weight and lifestyle (including calorie intake and exercise) throughout the clinical study period and within 6 months after the end of the study;
- •Non-pregnant and breastfeeding women who have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and the whole trial period, and have no sperm or egg donation plan.
排除标准
- •Patients who gained or lost more than 2.5 kg of weight during the study;
- •Patients who have used weight loss drugs or participated in weight loss-related programs within 6 months of the start of the study;
- •Have received or are about to receive surgery or liposuction in the abdomen, or have received lipolytic drugs injected in the abdomen, or have received abdominoplasty or cryo lipolysis;
- •History of abdominal/waist-related trauma or scar;
- •Patients with excessive accumulation of abdominal skin affecting the operation;
- •Implantation of metal-related articles in the abdomen;
- •Patients suffering from severe systemic diseases that are life-threatening (such as cardiac insufficiency, renal insufficiency, etc.);
- •Those who are equipped with dentures, pacemakers, or other internal metal implants (such as metal IUD rings, etc.);
- •Local skin infection and open skin injury;
- •Have a history of eating disorder or eating disorder;
- •Pregnant or breastfeeding women.
结局指标
主要结局
Height of abdominal subcutaneous adipose tissue
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 (Week 1 after last treatment), Week 14 (Month 1 after last treatment), Week 22 (Month 3 after last treatment)
Ultrasound (GE LogiQ P6 ultrasound system, 132 GE Healthcare, Wauwatosa, WI) was used to measure the height of abdominal subcutaneous adipose tissue at four positions below the left and right abdomen three times respectively. A mold plate was designed to fix the ultrasound probe, centered on the umbilicus, and symmetrically symmetrically. Areas A and B are horizontal measurement of ultrasonic probe, which are located above and below the left/right abdomen respectively, and areas C and D are vertical measurement of ultrasonic probe, which are located outside and inside respectively.Each measurement site was divided into three measurements and the average value was taken, and the overall average value of the three averages of each site was taken as the final value.
次要结局
未报告次要终点
研究者
Chengxin Li
Professor.
Chinese PLA General Hospital