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

Overview

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.

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.