A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
NCT ID: NCT06974955
Last Updated: 2025-05-16
Study Results
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Basic Information
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NOT_YET_RECRUITING
365 participants
OBSERVATIONAL
2025-05-31
2025-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients who have previously undergone surgery using the Mantra™ Surgical Robotic System 3.0
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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Clicebo Solutions Private Limited
OTHER
Sudhir Srivastava Innovations Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. Somashekhar S P, MBBS, MS, MCh, FRCS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Aster CMI Hospital
Locations
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ASTER CMI Hospital
Bangalore, Karnataka, India
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Ballantyne GH. The pitfalls of laparoscopic surgery: challenges for robotics and telerobotic surgery. Surg Laparosc Endosc Percutan Tech. 2002 Feb;12(1):1-5. doi: 10.1097/00129689-200202000-00001.
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
Related Links
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Other Identifiers
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CSPL/REG/2025/01
Identifier Type: -
Identifier Source: org_study_id
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