A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Soft Tissue Surgeries. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-World, Multicenter, Retrospective Study to Evaluate the Clinical Performance and Safety of MantraTM 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.
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.
Primary outcome measures
- Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP) [Time frame: 1 day]
- Successful completion of procedures without the need for conversion [Time frame: 1 day]
- Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure [Time frame: 30 days]
- Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events [Time frame: 30 day]
Secondary outcome measures (12)
- Operative Time - Measured from skin incision to skin closure to assess efficiency [Time frame: 1 day]
- Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery [Time frame: 1 day]
- Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion [Time frame: 1 day]
- Intraoperative Complications - Identification and classification of adverse events occurring during surgery [Time frame: 1 day]
- Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations [Time frame: 1 day]
- Length of Hospital Stay - Time from hospital admission to discharge post-surgery [Time frame: 30 days]
- Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions [Time frame: 30 days]
- Reoperation within 30 Days - Incidence of repeat surgical interventions [Time frame: 30 days]
- Mortality Rate at 30 Days - Evaluation of patient survival post-procedure [Time frame: 30 days]
- Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage [Time frame: 1 day]
- All Adverse Events - Monitoring of all minor and major adverse events related to surgery [Time frame: 30 days]
- Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
\- 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
Exclusion criteria
- Patients with missing data on primary endpoints.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
India · 1 center
- ASTER CMI Hospital — Bangalore
Publications
- Stoianovici DC, Patriciu A, Mazilu D, et al. AcuBot: a robot for radiological interventions. IEEE Trans Rob Autom. 2003; 19: 926-30.
- Gomez G. Sabiston Textbook of Surgery. 17th ed. Philadelphia, Pa: Elsevier Saunders; 2004. Emerging Technology in surgery: informatics, electronics, robotics.
- US Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff. Food and Drug Administration. 2017 Aug 31
- Hutchinson A. The top 50 inventions of the past 50 years. Popular Mechanics. December 2005.
- Boctor EM, Choti MA, Burdette EC, Webster Iii RJ. Three-dimensional ultrasound-guided robotic needle placement: an experimental evaluation. Int J Med Robot. 2008 Jun;4(2):180-91. doi: 10.1002/rcs.184. PMID 18433079
- Cadeddu JA, Bzostek A, Schreiner S, Barnes AC, Roberts WW, Anderson JH, Taylor RH, Kavoussi LR. A robotic system for percutaneous renal access. J Urol. 1997 Oct;158(4):1589-93. PMID 9302179
- Harris SJ, Arambula-Cosio F, Mei Q, Hibberd RD, Davies BL, Wickham JE, Nathan MS, Kundu B. The Probot--an active robot for prostate resection. Proc Inst Mech Eng H. 1997;211(4):317-25. doi: 10.1243/0954411971534449. PMID 9330543
- Tan GY, Goel RK, Kaouk JH, Tewari AK. Technological advances in robotic-assisted laparoscopic surgery. Urol Clin North Am. 2009 May;36(2):237-49, ix. doi: 10.1016/j.ucl.2009.02.010. PMID 19406324
Identifiers
NCT: NCT06974955 · CSPL/REG/2025/01