Remote telesurgery using Mantra Surgical robotic system.

Not Applicable

Conditions: Health Condition 1: O- Medical and Surgical

Registration Number: CTRI/2024/06/068361

Lead Sponsor: Sudhir Srivastava Innovations Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Male or Female patients with age of eighteen (18) and above.

Able to give written informed consent.

Patients meeting the inclusion criteria for general surgery such as the following surgical procedures using multi-arm robotic system for soft tissue surgeries:

Cholecystectomy

Inguinal Hernia Repair

Ventral Hernia Repair

Appendectomy

Ovarian Cystectomy

Exclusion Criteria

Patients who have participated in another investigational clinical study within thirty (30) days before screening

Inability to provide informed consent

Uncontrolled hypertension, diabetes mellitus or any other co- morbidity that is considered as a high risk for the planned surgical procedure

Patients who fall into New York Heart Association (NYHA) Class III or IV

History of chronic alcohol or drug abuse.

Chronic renal failure or on dialysis.

Subjects with any other clinically significant unstable medical condition, life-threatening disease, or anything else in the opinion of the Investigator that would contra-indicate a surgical procedure.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System tasks required for execution of the predefined procedures was feasible without impacting safety and performance. <br/ ><br> <br/ ><br>Latency did not interfere with the execution of predefined procedures. <br/ ><br> <br/ ><br>No interruptions due to Network Bandwidth and/ or stability. <br/ ><br> <br/ ><br>Device related adverse events.Timepoint: Procedure (Visit 2) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Data packet loss <br/ ><br> <br/ ><br>Cybersecurity measures- Data Encryption & Data Integrity <br/ ><br> <br/ ><br>Operative time – from incision to skin closure <br/ ><br> <br/ ><br>Blood loss during the surgery <br/ ><br> <br/ ><br>Length of hospital stay <br/ ><br> <br/ ><br>Return to the operating room within 24 hours of surgery <br/ ><br> <br/ ><br>Rate of hospital readmission after discharge (Noted during the entire duration of the study) <br/ ><br> <br/ ><br>Ease of the system by surgeons & operating <br/ ><br> <br/ ><br>Adverse events during the follow-up period per protocol.Timepoint: Visit 3, Visit 4 & Visit 5