A Real-World, Multicenter, Retrospective Study to Evaluate the Clinical Performance and Safety of MantraTM Surgical Robotic System for Soft Tissue Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP)
研究概览
简要总结
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
The purpose of this retrospective study is to evaluate the clinical performance and safety of the Mantra™ Surgical Robotic System, Model 3.0, for soft tissue surgeries. It aims to provide real-world evidence on the system's reliability, safety, and effectiveness in the real world population. The SSI Mantra 3.0 Surgical Robotic System is an advanced, modular, and cost-effective robotic-assisted surgical platform designed to enhance precision, flexibility, and control in minimally invasive surgeries (MIS).
The objective of this retrospective study is to assess the clinical performance and safety of the Mantra™ Surgical Robotic System in performing various soft tissue surgeries based on retrospective data analysis.
详细描述
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
Objective : To assess the clinical performance and safety of the Mantra™ Surgical Robotic System in performing various soft tissue surgeries based on retrospective data analysis.
Study Outcomes: The retrospective analysis of the Mantra Surgical Robotic System focused on evaluating its clinical performance, safety and efficacy in minimally invasive surgeries. The study outcomes were assessed based on surgical safety and efficacy parameters, intraoperative efficiency, post-operative recovery, and system utilization trends.
Primary Study Outcomes
- Primary Effectiveness Endpoint
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be eligible for inclusion in this retrospective clinical study of the SSI Mantra 3.0 Surgical Robotic System.
- •Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System (Model 3.0) for the following procedures mentioned in Appendix D
排除标准
- •Patients with missing data on primary endpoints.
结局指标
主要结局
Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP)
时间窗: 1 day
• Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP).
Successful completion of procedures without the need for conversion
时间窗: 1 day
Successful completion of procedures without the need for conversion
Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
时间窗: 30 days
Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
时间窗: 30 day
Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
次要结局
- Operative Time - Measured from skin incision to skin closure to assess efficiency(1 day)
- Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery(1 day)
- Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion(1 day)
- Intraoperative Complications - Identification and classification of adverse events occurring during surgery(1 day)
- Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations(1 day)
- Length of Hospital Stay - Time from hospital admission to discharge post-surgery(30 days)
- Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions(30 days)
- Reoperation within 30 Days - Incidence of repeat surgical interventions(30 days)
- Mortality Rate at 30 Days - Evaluation of patient survival post-procedure(30 days)
- Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage(1 day)
- All Adverse Events - Monitoring of all minor and major adverse events related to surgery(30 days)
- Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms(1 day)