Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: MantraTM Surgical Robotic System, Model 3.0: Robotic surgery used in conditions for:
i. Cholecystectomy
ii. Hysterectomy
iii. Nephrectomy
iv. Prostatectomy
v. Oesophagus mobilizatio
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 one of the following surgical procedures using MantraTM Surgical Robotic System, Model 3.0 for soft tissue surgeries: Cholecystectomy Hysterectomy Nephrectomy Prostatectomy Oesophagus mobilization Internal Mammary Artery takedown Cystectomy Lung Lobectomy Nephron Sparing Surgery Bilateral Pelvic Lymph Node Dissection Radical Cystoprostatectomy Partial Nephrectomy
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 Comorbidities such as hypertension, diabetes mellitus or any other co-morbidities 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 could be performed safely on predefined procedures. System tasks required for the performance of predetermined procedures. System tasks required are feasible and could be carried out effectively. Device related adverse events.Timepoint: Procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Ease of the system by surgeons and operating room staff. 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) Adverse events during the follow-up period per protocol. Timepoint: Post Procedure till End of Study | — |
Countries
India
Contacts
Public ContactPriyadarshini Arambam
Sudhir Srivastava Innovations Pvt. Ltd.
Outcome results
None listed