Clinical trial NCT06974955: A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
Official title: A Real-World, Multicenter, Retrospective Study to Evaluate the Clinical Performance and Safety of MantraTM Surgical Robotic System for Soft Tissue Surgeries
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Soft Tissue Surgeries
Keywords: Retrospective Study
Real World
Mantra TM Surgical Robotic System
soft tissue surgeries
Lead sponsor: Sudhir Srivastava Innovations Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clicebo Solutions Private Limited
First posted: 2025-05-16
Enrollment: 365
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients who have undergone soft tissue surgeries using the Mantra™ Surgical Robotic System (3.0)

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.

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.

Primary outcomes:
measure: Rate of Unplanned Conversion to other minimally invasive surgery (MAS) or open surgery (OP)
timeFrame: 1 day
measure: Successful completion of procedures without the need for conversion
timeFrame: 1 day
measure: Rate of intraoperative and postoperative serious adverse events (SAEs) occurring up to 30 days post-procedure
timeFrame: 30 days
measure: Evaluation of surgical complications, including infections, haemorrhage, and device-related adverse events
timeFrame: 30 day
Secondary outcomes:
measure: Operative Time - Measured from skin incision to skin closure to assess efficiency
timeFrame: 1 day
measure: Estimated Blood Loss (Intraoperative) - Quantification of Blood loss during surgery
timeFrame: 1 day
measure: Need for Blood Transfusion - Evaluation of cases requiring intraoperative blood transfusion
timeFrame: 1 day
measure: Intraoperative Complications - Identification and classification of adverse events occurring during surgery
timeFrame: 1 day
measure: Return to Operating Room within 24 Hours - Evaluation of unplanned reoperations
timeFrame: 1 day
measure: Length of Hospital Stay - Time from hospital admission to discharge post-surgery
timeFrame: 30 days
measure: Readmission to Hospital within 30 Days - Tracking of unexpected hospital readmissions
timeFrame: 30 days
measure: Reoperation within 30 Days - Incidence of repeat surgical interventions
timeFrame: 30 days
measure: Mortality Rate at 30 Days - Evaluation of patient survival post-procedure
timeFrame: 30 days
measure: Device Deficiencies and Use Errors - Documentation of device-related malfunctions or improper usage
timeFrame: 1 day
measure: All Adverse Events - Monitoring of all minor and major adverse events related to surgery
timeFrame: 30 days
measure: Device Performance Metrics - Assessment of unplanned instrument usage, robotic arm clashes, collision detection, and system-generated alarms
timeFrame: 1 day
Other outcomes:
Locations:
city: Bangalore
country: India
facility: ASTER CMI Hospital
state: Karnataka
Study officials:
affiliation: Aster CMI Hospital
name: Prof. Dr. Somashekhar S P, MBBS, MS, MCh, FRCS, FRCS
role: PRINCIPAL_INVESTIGATOR
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