A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries

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

1. Primary Effectiveness Endpoint

* Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP). * Successful completion of the procedure using the SSI Mantra 3.0 Surgical Robotic System as planned. 2. Primary Safety Endpoint

* Rate of Total Intraoperative and Postoperative Serious Adverse Events (SAE) up to 30 days post-procedure. * Assessment of device-related complications . Secondary Study Outcomes

1\. Operative Time

* Measured from skin incision to skin closure to assess efficiency. 2. Estimated Blood Loss (Intraoperative) * Quantification of blood loss during surgery. 3. Need for Blood Transfusion * Evaluation of cases requiring intraoperative blood transfusion. 4. Intraoperative Complications * Identification and classification of adverse events occurring during surgery. 5. Return to Operating Room within 24 Hours * Evaluation of unplanned reoperations. 6. Length of Hospital Stay * Time from hospital admission to discharge post-surgery. 7. Readmission to Hospital within 30 Days * Tracking of unexpected hospital readmissions. 8. Reoperation within 30 Days * Incidence of repeat surgical interventions. 9. Mortality Rate at 30 Days * Evaluation of patient survival post-procedure. 10. Device Deficiencies and Use Errors * Documentation of device-related malfunctions or improper usage. 11. All Adverse Events * Comprehensive assessment of both minor and major adverse effects. 12. Device Performance Data * Monitoring of unplanned instrument usage, system clashes, collision detection, and alarm activations.

Timepoints: Day of surgery - 30 days (follow-up). Study Design: This is a retrospective, multicentre study designed to collect and analyze data from surgeries performed using the Mantra™ Surgical Robotic System, Models 3.0,. The study will evaluate clinical performance, safety, and patient outcomes across approximately twenty centers with a target sample size of 365 patients.

• Operative Time - Measured from skin incision to skin closure to assess efficiency [Срок оценки: 1 day]
• Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery [Срок оценки: 1 day]
• Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion [Срок оценки: 1 day]
• Intraoperative Complications - Identification and classification of adverse events occurring during surgery [Срок оценки: 1 day]
• Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations [Срок оценки: 1 day]
• Length of Hospital Stay - Time from hospital admission to discharge post-surgery [Срок оценки: 30 days]
• Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions [Срок оценки: 30 days]
• Reoperation within 30 Days - Incidence of repeat surgical interventions [Срок оценки: 30 days]
• Mortality Rate at 30 Days - Evaluation of patient survival post-procedure [Срок оценки: 30 days]
• Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage [Срок оценки: 1 day]
• All Adverse Events - Monitoring of all minor and major adverse events related to surgery [Срок оценки: 30 days]
• Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms [Срок оценки: 1 day]