Versius Clinical Study in Robot Assisted Total Hysterectomy
- Conditions
- 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
Study Title:Prospective Clinical Study to Evaluate the Safety and Efficacy of theVersius Surgical System in Robot-Assisted Total Hysterectomy
Objective: To evaluate the Safety and Efficacy of the Versius Surgical Robotic System inrobotically assisted total hysterectomy (RATH) surgical procedures. Measured byincidence of serious adverse events and successful completion of the surgerywithout conversion to laparoscopic or open surgery, respectively.
Study Design: A prospective cohort study as
PreoperativeScreening>IntraoperativeHospital Stay>PostoperativeFollow up DIscharge Day>PostoperativeFollow upDay 42±2
Product: The Versius Surgical Robotic System (Versius®)
Study Population: Patients suitable for Robot assisted- minimal access total hysterectomy surgeriesusing Versius® (as determined by the Principal Investigator), above 18 years of age.
Procedure Type: Minimal access Robot-Assisted Total Hysterectomy procedures
Primary EfficacyOutcome:Rate of successful completion of robotic assisted surgery without unplannedconversion to other laparoscopic or open surgery
Primary SafetyOutcome:Incidence of Serious Adverse Events up to 30 days post operation
Secondary Outcomes:
1. Operative time – From incision to skin closure
2. Estimated blood loss (intra-operative)
3. Blood transfusion (intra-operative)
4. Intra-operative complications
5. Return to operating room within 24 hours
6. Length of hospital stay
7. Readmission to hospital within 30 days
8. Reoperation within 30 days
9. Mortality rate at 30 days
10. Vaginal Vault healing at 42 days post-operative
11. Histopathology of surgically removed specimen
12. Device deficiencies and use errors regardless of relationship to anadverse event
13. All Adverse Events
14. Device performance data including unplanned instrument usage, clashes,collision detection, alarms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 30
- 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.
- 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.
- 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 Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without 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. unplanned conversion to other laparoscopic or open surgery). 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. Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure. 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. Primary Efficacy Outcome: 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. Primary Safety Outcome: 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 Outcome Measures
Name Time Method Secondary Endpoints: • Operative time – From skin incision to skin closure
Trial Locations
- Locations (1)
HCG Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
HCG Manavata Cancer Centre🇮🇳Nashik, MAHARASHTRA, IndiaDr Raj NagarkarPrincipal investigator09823061929drraj@manavatacancercentre.com