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Clinical Trials in India / NCT06974955
Starting soon Observational

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

NCT06974955 · tracked via the Priya Life Science India tracker
Sponsor
Sudhir Srivastava Innovations Pvt. Ltd
Phase
Observational
Started
2025-05
Last updated
2025-05-16

Condition(s) studied

Soft Tissue Surgeries

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
ASTER CMI Hospital Bangalore Karnataka
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06974955 on ClinicalTrials.gov ↗ ← All trials in India