A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
- Conditions
- Soft Tissue Surgeries
- Registration Number
- NCT06974955
- Lead Sponsor
- Sudhir Srivastava Innovations Pvt. Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 365
- 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
- Patients with missing data on primary endpoints.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP) 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 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 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 30 day Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
- Secondary Outcome Measures
Name Time Method Operative Time - Measured from skin incision to skin closure to assess efficiency 1 day Measured from skin incision to skin closure to assess efficiency
Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery 1 day Quantification of blood loss during surgery
Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion 1 day Evaluation of cases requiring intraoperative blood transfusion
Intraoperative Complications - Identification and classification of adverse events occurring during surgery 1 day Identification and classification of adverse events occurring during surgery
Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations 1 day Evaluation of unplanned reoperations
Length of Hospital Stay - Time from hospital admission to discharge post-surgery 30 days Time from hospital admission to discharge post-surgery
Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions 30 days Tracking of unexpected hospital readmissions
Reoperation within 30 Days - Incidence of repeat surgical interventions 30 days Incidence of repeat surgical interventions
Mortality Rate at 30 Days - Evaluation of patient survival post-procedure 30 days Evaluation of patient survival post-procedure
Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage 1 day Documentation of device-related malfunctions or improper usage
All Adverse Events - Monitoring of all minor and major adverse events related to surgery 30 days Monitoring of all minor and major adverse events related to surgery
Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms 1 day Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms
Trial Locations
- Locations (1)
ASTER CMI Hospital
🇮🇳Bangalore, Karnataka, India
ASTER CMI Hospital🇮🇳Bangalore, Karnataka, India