Product Surveillance Registry(PSR)
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- To demonstrate the overall complication rate through 30 days in patients undergoing surgery with the Medtronic Robotic Assisted Surgical Device (RASD)
研究概览
简要总结
The purpose of this registry is- Safety and efficacy of the Medtronic Robotic Assisted Surgical Device (RASD) demonstrated through pre-market Design Verification, Validation and Usability testing. The purpose of the registry is to confirm clinical safety and performance of the RASD (Robotic-Assisted Surgical Device ) when used as intended in real-world setting. Data will be collected through Medtronic’s Post Market Surveillance platform, the Product Surveillance Registry (PSR), and be used for regulatory decision-making purposes.
The PSR registry is global and India is one of the contribution nation for the real worlds data collection as mentioned above.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible product (Section 3.3) Patient is consented within the enrollment window of the treatment/therapy received, refer to the applicable Condition/Therapy Appendix.
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).
结局指标
主要结局
To demonstrate the overall complication rate through 30 days in patients undergoing surgery with the Medtronic Robotic Assisted Surgical Device (RASD)
时间窗: 30 days
Complications included in the primary objective are device and procedure related adverse events occurring to patients intra-operatively and post-operatively through 30 days
时间窗: 30 days
次要结局
- The secondary objective is intended to gain additional information about the safety and performance of the Medtronic RASD, to allow for data stratification and subgroup analysis and to assess learning curve. There will be no established performance goals related to the secondary objective.