Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Versius - A Surgical Robotic System: Preoperative Screening
Intraoperative Hospital Stay
Postoperative Follow up DIscharge Day
Postoperative Follow up Day 42�±2
Control Interven
Sponsors
CMR Surgical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient deemed suitable for total laparoscopic hysterectomy procedure using Versius Surgical Robotic System 2. Patients able to provide written informed consent to participate in the study (with help of appropriate legal representatives if required) 3. Female, aged 18 years or above 4. Female of childbearing potential, must not be pregnant 5. Patients with BMI �40. Ideally BMI �25 to � 40
Exclusion criteria
Exclusion criteria: 1. Patient participation in an investigational clinical study within 30 days before screening 2. Inability or difficulties to provide informed consent 3. Oncological cases, patients undergoing surgery or treatment for malignant disease 4. Patients who fall into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix B) 5. Uterus size of > 14 weeks 6. History of chronic alcohol or drug abuse 7. Chronic renal failure or on dialysis 8. Significant medical history or immunocompromised 9. Subjects with any other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure 10. Patient tested COVID positive within last 30 days of screening 11. Patient tested COVID positive within 48 hours within procedure 12. Diabetes mellitus (Glycemia > 11mmol/L; >200 mg/dL) 13. Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome: Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without unplanned conversion to other laparoscopic or open surgery). Primary Safety Outcome: Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure.Timepoint: Primary Efficacy Outcome: Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without unplanned conversion to other laparoscopic or open surgery). Primary Safety Outcome: Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: ââ?¬Â¢ Operative time ââ?¬â?? From skin incision to skin closure ââ?¬Â¢ Estimated blood loss (intra-operative) ââ?¬Â¢ Blood transfusion (during hospitalization) ââ?¬Â¢ Intra-operative complications ââ?¬Â¢ Return to operating room within 24 hours ââ?¬Â¢ Length of hospital stay ââ?¬Â¢ Readmission to hospital within 30 days ââ?¬Â¢ Reoperation within 30 days ââ?¬Â¢ Mortality rate at 30 days ââ?¬Â¢ Vaginal Vault healing at 42 days post-operative ââ?¬Â¢ Histopathology of surgically removed specimen ââ?¬Â¢ Device deficiencies and use errors regardless of relationship to an adverse event ââ?¬Â¢ All Adverse Events ââ?¬Â¢ Device performance data including unplanned instrument usage, clashes, collision detection, alarms.Timepoint: ââ?¬Â¢ Vaginal Vault healing at 42 days post-operative | — |
Countries
India
Contacts
Public ContactDr Manisha Jadhav
CMR Surgical India Pvt Ltd
Outcome results
None listed