The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife
研究概览
简要总结
Evaluation of the safety and effectiveness of disposable ultrasound soft tissue cutting and hemostasis equipment for coagulating 5-7mm blood vessels with ultrasound scalpel tips
详细描述
Screening lung and esophageal surgery patients who must meet the inclusion/exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of 5-7mm blood vessel disconnection and occlusion
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 75 years old, regardless of gender;
- •Based on the preoperative CT examination results, it is determined that the patient has at least one blood vessel that needs to be coagulated during the surgery, with a diameter greater than 5mm but less than or equal to 7mm;
- •Before the start of the study, the patient is willing and able to sign an informed consent form approved by the ethics committee;
- •The patient understands the clinical study, cooperates with the research procedure, and is willing to conduct postoperative follow-up according to the protocol.
排除标准
- •Patient body mass index (BMI) ≥ 35.0 kg/m2;
- •Prothrombin time greater than 5 seconds;
- •Researchers have determined that the tumor may invade the target blood vessel, which may affect the operation or effectiveness of vascular occlusion and disconnection;
- •Researchers have determined that there may be variations, deformities, or calcifications in the target vessel that may affect the evaluation of the primary endpoint, which may affect the operation or effectiveness of vascular occlusion and disconnection;
- •Patients receive preoperative chemotherapy and radiation therapy;
- •Patient's fasting blood glucose ≥ 11.1mmol/l;
- •Hypertensive patients' blood pressure has not been effectively controlled, and their blood pressure is ≥ 140/90 millimeter of mercury （mmHg） in a stable state after medication;
- •Pregnant or lactating women, or women with pregnancy plans during the trial period;
- •Participated in other clinical studies within 3 months;
- •Individuals with mental disorders and lack of autonomous behavioral ability;
- •Other researchers believe that it is not suitable to participate in the experiment.
结局指标
主要结局
The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife
时间窗: From the target Vascular detachment to finish of the surgery
The success rate is defined as the number of subjects who successfully occluded and severed blood vessels divided by the number of subjects in the analysis dataset. Each subject should use an ultrasound knife to occlude and sever at least one target vessel
次要结局
未报告次要终点
研究者
Hecheng Li M.D., Ph.D
Prof
Ruijin Hospital