Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Number of Participants With Anastomosis Success
研究概览
简要总结
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson & Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
详细描述
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson & Johnson.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A test method in which subjects are not told whether they are a trial device or a control device in order to control intentional or unintentional bias in the course of a clinical trial and in the interpretation of results
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
- •The subjects are 18 ~ 75 years old, regardless of gender:
- •Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis:
- •The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent.
排除标准
- •The subject plans to perform emergency gastrointestinal surgery:
- •Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g / L):
- •Subject BMI 228kg / m2;
- •Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5;
- •Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%;
- •Subject's cardiac ejection fraction ≤ 50%;
- •Have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum creatinine (SER) exceeds normal values
- •Upper limit 3 times and above: subjects with fasting blood glucose value > 10.0mmol/l before operation:
- •The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue
- •Subjects participated in clinical trials of other drugs or devices within 3 months before the trial;
- •Other conditions that the researchers judged not suitable for inclusion.
研究组 & 干预措施
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
干预措施: Disposable Powered Articulating Endoscopic Linear Cutter Stapler (Device)
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
干预措施: ECHELON Flex Powered Articulating Endoscopic Linear Cutters (Device)
结局指标
主要结局
Number of Participants With Anastomosis Success
时间窗: During surgery
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure.
次要结局
未报告次要终点