Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Mantra Surgical robotic system Model 2.0: Remote telesurgery used in conditions for:
Cholecystectomy: Total surgery time 1.5Hrs
Inguinal Hernia Repair: Total surgery time 2.5Hrs
Ven
Sponsors
Sudhir Srivastava Innovations Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| System tasks required for execution of the predefined procedures was feasible without impacting safety and performance. Latency did not interfere with the execution of predefined procedures. No interruptions due to Network Bandwidth and/ or stability. Device related adverse events.Timepoint: Procedure (Visit 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Data packet loss Cybersecurity measures- Data Encryption & Data Integrity Operative time – from incision to skin closure Blood loss during the surgery Length of hospital stay Return to the operating room within 24 hours of surgery Rate of hospital readmission after discharge (Noted during the entire duration of the study) Ease of the system by surgeons & operating Adverse events during the follow-up period per protocol.Timepoint: Visit 3, Visit 4 & Visit 5 | — |
Countries
India
Contacts
Public ContactPriyadarshini Arambam
Sudhir Srivastava Innovations Pvt. Ltd.
Outcome results
None listed