Medtronic Signia Small Diameter Reload Product Surveillance Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 430
- 试验地点
- 24
- 主要终点
- Incidence of Intraoperative Hemostatic Intervention
研究概览
简要总结
The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
- •Patient has, or is intended to receive or be treated with, an eligible Medtronic product
- •Patient is consented within the enrollment window of the therapy received, as applicable
排除标准
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Patient is excluded by local law
- •Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results
结局指标
主要结局
Incidence of Intraoperative Hemostatic Intervention
时间窗: During Procedure
* Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins. * Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins. * Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis).
次要结局
- Incidence of Repeat Hospital Admission for Primary Procedure-related Complications(30 days)
- Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale(During Procedure)
- Intraoperative Assessments: Incidence of Staple Line Bleeding(During Procedure)
- Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure(During Procedure)
- Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure(30 days)
- Device Deficiencies(30-days)