Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted cholecystectomy (a surgical procedure to remove your gallbladder)

Phase 2

• Conditions: Robot assisted cholecystectomy; Surgery

• Registration Number: ISRCTN17254664
• Lead Sponsor: CMR Surgical (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-20
• Last Update Posted: 31 October 2022
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

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 kg/m². Priority BMI 25 to 40 kg/m²

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

Primary Outcome Measures

Name	Time	Method
<br> Primary efficacy outcome:<br> Rate of successful completion of robot assisted surgery without unplanned conversion to other laparoscopic or open surgery, as recorded on the data entry platform<br><br> Primary safety outcome:<br> Incidence of serious adverse events, recorded on the data entry platform at any time between commencement of surgery (intraoperative) to the end of the trial (postoperative, between incidence of surgery to 30 days after surgery)<br>