A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy index
研究概览
简要总结
The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
- •18 to 60 years old;
- •Agree to sign the informed consent;
排除标准
- •Patients with severe liver and kidney dysfunction;
- •Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;
- •Patients with cardiovascular disease;
- •People with hematological diseases;
- •Patients with hypertension and diabetes;
- •People with mental illness;
- •Pregnant and lactating women.
结局指标
主要结局
Efficacy index
时间窗: 6 month after treatment
Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%
次要结局
- Recurrence rate(6 month after treatment)