Versius Clinical Study

Phase 4

• Conditions: Health Condition 1: K808- Other cholelithiasis

• Registration Number: CTRI/2022/08/045073
• Lead Sponsor: CMR Surgical India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified