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| Name | Class |
|---|---|
| Clicebo Solutions Private Limited | OTHER |
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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
Primary Effectiveness Endpoint
Primary Safety Endpoint
1. Operative Time
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System 3.0 |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP) | • Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP). | 1 day |
| Successful completion of procedures without the need for conversion | Successful completion of procedures without the need for conversion | 1 day |
| Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure | Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure | 30 days |
| Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events | Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time - Measured from skin incision to skin closure to assess efficiency | Measured from skin incision to skin closure to assess efficiency | 1 day |
| Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery |
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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:
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The study population will include patients who have undergone soft tissue surgeries using the Mantra™ Surgical Robotic System (3.0)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Shokeen | Contact | 91+9958002162 | Sonia.shokeen@ssinnovations.org | |
| Priyadarshini Arambam | Contact | 91+9910990347 | regulatory@clicebo.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Somashekhar S P, MBBS, MS, MCh, FRCS, FRCS | Aster CMI Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASTER CMI Hospital | Bangalore | Karnataka | 560092 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Stoianovici DC, Patriciu A, Mazilu D, et al. AcuBot: a robot for radiological interventions. IEEE Trans Rob Autom. 2003; 19: 926-30. | ||
| Background | Gomez G. Sabiston Textbook of Surgery. 17th ed. Philadelphia, Pa: Elsevier Saunders; 2004. Emerging Technology in surgery: informatics, electronics, robotics. | ||
| Background | 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 | ||
| Background | Hutchinson A. The top 50 inventions of the past 50 years. Popular Mechanics. December 2005. | ||
| 18433079 |
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| Related Info | View source |
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Quantification of blood loss during surgery
| 1 day |
| Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion | Evaluation of cases requiring intraoperative blood transfusion | 1 day |
| Intraoperative Complications - Identification and classification of adverse events occurring during surgery | Identification and classification of adverse events occurring during surgery | 1 day |
| Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations | Evaluation of unplanned reoperations | 1 day |
| Length of Hospital Stay - Time from hospital admission to discharge post-surgery | Time from hospital admission to discharge post-surgery | 30 days |
| Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions | Tracking of unexpected hospital readmissions | 30 days |
| Reoperation within 30 Days - Incidence of repeat surgical interventions | Incidence of repeat surgical interventions | 30 days |
| Mortality Rate at 30 Days - Evaluation of patient survival post-procedure | Evaluation of patient survival post-procedure | 30 days |
| Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage | Documentation of device-related malfunctions or improper usage | 1 day |
| All Adverse Events - Monitoring of all minor and major adverse events related to surgery | 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 | Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms | 1 day |
| Background |
| 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. |
| 9302179 | Background | 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. |
| 9330543 | Background | 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. |
| 19406324 | Background | 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. |
| 20428333 | Background | Kazanzides P, Fichtinger G, Hager GD, Okamura AM, Whitcomb LL, Taylor RH. Surgical and Interventional Robotics: Core Concepts, Technology, and Design. IEEE Robot Autom Mag. 2008 Jun 1;15(2):122-130. doi: 10.1109/MRA.2008.926390. No abstract available. |
| 16538515 | Background | Sim HG, Yip SK, Cheng CW. Equipment and technology in surgical robotics. World J Urol. 2006 Jun;24(2):128-35. doi: 10.1007/s00345-006-0070-6. Epub 2006 Mar 15. |
| Background | H. Lavery, D. Samadi, and A. Levinson, "Not a zerosum game: the adoption of robotics has increased overall prostatectomy utilization in the united states," in Proceedings of the American Urological Association Annual Meeting, Poster Session,Washington, DC, USA, 2011. |
| 15231856 | Background | Hashizume M, Tsugawa K. Robotic surgery and cancer: the present state, problems and future vision. Jpn J Clin Oncol. 2004 May;34(5):227-37. doi: 10.1093/jjco/hyh053. |
| 15476646 | Background | Camarillo DB, Krummel TM, Salisbury JK Jr. Robotic technology in surgery: past, present, and future. Am J Surg. 2004 Oct;188(4A Suppl):2S-15S. doi: 10.1016/j.amjsurg.2004.08.025. |
| 15475097 | Background | Marohn MR, Hanly EJ. Twenty-first century surgery using twenty-first century technology: surgical robotics. Curr Surg. 2004 Sep-Oct;61(5):466-73. doi: 10.1016/j.cursur.2004.03.009. |
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| Related Info | View source |