Versius Clinical Study in Robot Assisted Total Hysterectomy
- Conditions
- Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
- Registration Number
- CTRI/2022/09/045789
- Lead Sponsor
- CMR Surgical India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Outcome: <br/ ><br>Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without <br/ ><br>unplanned conversion to other laparoscopic or open surgery). <br/ ><br> <br/ ><br>Primary Safety Outcome: <br/ ><br>Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure.Timepoint: Primary Efficacy Outcome: <br/ ><br>Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without <br/ ><br>unplanned conversion to other laparoscopic or open surgery). <br/ ><br> <br/ ><br>Primary Safety Outcome: <br/ ><br>Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure.
- Secondary Outcome Measures
Name Time Method Secondary Endpoints: <br/ ><br>ââ?¬Â¢ Operative time ââ?¬â?? From skin incision to skin closure <br/ ><br>ââ?¬Â¢ Estimated blood loss (intra-operative) <br/ ><br>ââ?¬Â¢ Blood transfusion (during hospitalization) <br/ ><br>ââ?¬Â¢ Intra-operative complications <br/ ><br>ââ?¬Â¢ Return to operating room within 24 hours <br/ ><br>ââ?¬Â¢ Length of hospital stay <br/ ><br>ââ?¬Â¢ Readmission to hospital within 30 days <br/ ><br>ââ?¬Â¢ Reoperation within 30 days <br/ ><br>ââ?¬Â¢ Mortality rate at 30 days <br/ ><br>ââ?¬Â¢ Vaginal Vault healing at 42 days post-operative <br/ ><br>ââ?¬Â¢ Histopathology of surgically removed specimen <br/ ><br>ââ?¬Â¢ Device deficiencies and use errors regardless of relationship to an adverse event <br/ ><br>ââ?¬Â¢ All Adverse Events <br/ ><br>ââ?¬Â¢ Device performance data including unplanned instrument usage, clashes, collision detection, alarms.Timepoint: ââ?¬Â¢ Vaginal Vault healing at 42 days post-operative