Clinical Trial of Microwave Ablation System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Volume reduction rate of thyroid nodules
研究概览
简要总结
Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.
详细描述
Ultrasound-guided minimally invasive treatment has accurate positioning, higher targeting, no need for general anesthesia, less trauma for patients, and more reliable efficacy.Currently, it mainly includes percutaneous anhydrous ethanol injection, radiofrequency ablation and microwave ablation for the treatment of thyroid nodules.Currently, radiofrequency ablation and microwave ablation are mainly used to treat thyroid nodules.
This study was a randomized, parallel, positive control, and non-inferiority multicenter clinical study.Radiofrequency ablation was used as the positive control.Follow-up was conducted at 1, 3, 6 and 12 months after ablation. The primary endpoint was the rate of nodule volume reduction at 12 months after surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years and ≤75 years
- •The pathological diagnosis was benign thyroid nodules within 6 months
- •Diameter ≥2cm, solid > 80%, the number of multiple nodules≤ 3
- •Participate voluntarily and sign the informed consent
排除标准
- •Coagulation mechanism disorder or bleeding tendency
- •Patients with severe cardiopulmonary insufficiency
- •Blood pressure cannot be effectively controlled
- •abnormal liver function
- •Blood glucose cannot be effectively controlled
- •Abnormal thyroid function
- •Allergic history of ultrasound contrast agent
- •Suspicious lymph node metastasis in the cervical region
- •Abnormal contralateral vocal cord function
- •Pregnant and lactating women
- •Have participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment
- •The researchers believe that there are any other factors that are not suitable for inclusion or that affect participants' participation in the study.
- •Patients with inner pacemaker, hearing aid, metal stent, titanium clip, internal (external) steel plate and other metal objects.
结局指标
主要结局
Volume reduction rate of thyroid nodules
时间窗: up to 12 months.
volume reduction rate，VRR=(Volume before treatment - volume at follow-up)/Volume before treatment
次要结局
未报告次要终点
研究者
Yu Jie
Associate chief physician
Chinese PLA General Hospital