A Prospective, Multi-center, Randomized, Open-label, Parallel-controlled Non-inferiority Investigation to Evaluate the Efficacy and Safety of the Ultrasonic Surgical System in Clinical Applications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The overall excellent performance rate
研究概览
简要总结
The objective of this clinical investigation is to evaluate the efficacy and safety of the Ultrasonic Surgical System in the clinical application produced by Ezisurg Medical Co., Ltd.
详细描述
This clinical investigation is designed as a prospective, multi-center, randomized, parallel-controlled non-inferiority investigation, and the HARMONIC System produced by Ethicon Endo-Surgery, LLC is used as the control product.
Study objective：To evaluate the efficacy and safety of the Ultrasonic Surgical System in the clinical application produced by Ezisurg Medical Co., Ltd.
Target population：Patients who require open or endoscopic surgery using the Ultrasonic Surgical Instruments.
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
- •Subjects who voluntarily participate in the investigation and sign the Informed Consent Form;
- •Male or female subjects aged 18~75;
- •Patients who require open or endoscopic surgery using the Ultrasonic Surgical System;
- •Those who can communicate well with investigators and comply with investigational requirements.
排除标准
- •Patients with severe heart, liver, lung, kidney, brain, blood system diseases, severe metabolic diseases or unable to withstand surgery after systemic assessment;
- •Those who with obvious severe local or systemic infection;
- •Those who need to undergo the resection of bone tissue and central nervous tissue of the brain and the spinal cord;
- •Those who need to undergo contraceptive tubal ligation;
- •Those who have a history of alcohol or drug abuse within 6 months before the investigation;
- •Women who are pregnant or lactating, or women who plan to become pregnant within 6 months;
- •Those who with mental illness;
- •Those who have a history of allergies to multiple types of drugs or recent allergic diseases;
- •Those who have participated in other clinical investigations in the past 3 months;
- •Those who are inappropriate to participate in this clinical investigation for other reasons in the opinion of the investigators.
结局指标
主要结局
The overall excellent performance rate
时间窗: during the surgery
The overall excellent performance rate will be taken as the primary evaluation indicator. The clinical effect of the investigational product is mainly embodied by its cutting and coagulation functions, and the surgical operators will evaluate the cutting and coagulation functions of the product according to the following criteria.
次要结局
未报告次要终点