Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Anastomosis success rate
研究概览
简要总结
Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures.
In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old, gender unlimited;
- •The surgery type shall be open or endoscopic surgery;
- •The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
- •Investigational devices listed in this PMCF plan must be used during surgical procedures.
排除标准
- •Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range;
- •Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
- •The operation record is incomplete, and the information related to the main indicators cannot be extracted.
结局指标
主要结局
Anastomosis success rate
时间窗: The investigation sites will be collected from January 2023 to June 2024.
According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis.
次要结局
- Anastomotic bleeding rate(The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.)
- Anastomotic leakage rate(The incidence of leakage during day of operation and 6 months after operation was recorded.)
- Anastomotic stenosis rate(The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.)