Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Mantra Surgical Robotic System: Robotic Assisted Surgeries in conditions for cholesystectomy,hysterectomy, nephrectomy, prostatectomy, esophagus mobilization, internal mammary takedown
Sponsors
Robosurg Med Tech Pvt Ltd SS Innovations Group Company
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or Female patients with age of eighteen (18) and above. 2 Able to give written informed consent. 3 Patients meeting the inclusion criteria for one of the following surgical procedures using multi-arm robotic system for soft tissue surgeries: Cholecystectomy Hysterectomy Nephrectomy Prostatectomy Esophagus mobilization Internal Mammary Artery takedown Lung Lobectomy
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 |
|---|---|
| 1 System tasks could be performed safely on predefined procedures. 2 System tasks required for performance of predetermined procedures 3 System tasks required for feasible and could be carried out effectively. 4 Device related adverse events Timepoint: Day of surgery till end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Ease of the system by surgeons and operating room staff. Histopathology to see the clinical-pathological outcomes which will be compared with historical controls Operative time ââ?¬â?? from incision to skin closure Return to operating room within 24 hours of surgery Blood loss during the surgery Length of hospital stay Rate of hospital re admission after discharge (Noted during entire duration of study) Adverse events during the follow-up period per protocol. Timepoint: Day of surgery till end of study | — |
Countries
India
Contacts
Public ContactDr Sudhir Prem Srivastava
Rajiv Gandhi Cancer Institute and Research Centre
Outcome results
None listed