Health Condition 1: K808- Other cholelithiasis
Conditions
Sponsors
CMR Surgical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient deemed suitable for laparoscopic Cholecystectomy 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. Male and Female, aged 18 years or above 4. Female of childbearing potential, must not be pregnant and agree to not become pregnant for the duration of the study 5. Patients with BMI <40. Priority 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) ClassIV or above 5. History of chronic alcohol or drug abuse 6. Chronic renal failure or on dialysis 7. Significant medical history or immunocompromised 8. 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 9. Patient tested COVID positive within last 30 days of screening 10.Patient tested COVID positive within 48 hours day the of the procedure 11.Diabetes mellitus (Glycemia > 11mmol/L ; >200 mg/dL) 12. Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome: Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery Primary Safety Outcome: Incidence of Serious Adverse Events up to 30 days post operationTimepoint: Primary Efficacy Outcome: Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery Primary Safety Outcome: Incidence of Serious Adverse Events up to 30 days post operation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Operative time ââ?¬â?? 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. Histopathology of surgically removed specimen 11. Device deficiencies and use errors regardless of relationship to an adverse event 12. All Adverse Events 13. Device performance data including unplanned instrument usage, clashes,collision detection, alarms.Timepoint: Study duration | — |
Countries
India
Contacts
Public ContactDr Manisha Jadhav
CMR Surgical India Pvt Ltd.
Outcome results
None listed