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

Phase 2

• Conditions: Robot assisted total hysterectomy; Surgery

• Registration Number: ISRCTN11414606
• Lead Sponsor: CMR Surgical (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-03
• Last Update Posted: 14 November 2022
• Study Completion: 2023-03-31

Recruitment & Eligibility

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

Inclusion Criteria

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 kg/m². Ideally 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. Uncontrolled hypertension (=/>Systolic: 180 mmHg/Diastolic: 120 mmHg)
4. Diabetes mellitus (Glycemia >11mmol/L; >200 mg/dL)
5. Oncological cases, patients undergoing surgery or treatment for malignant disease
6. Patients who fall into American Society of Anaesthesiologists (ASA) Class IV or above
7. Uterus size of >14 weeks
8. History of chronic alcohol or drug abuse
9. Chronic renal failure or on dialysis
10. Significant medical history or immunocompromised
11. Subjects with any other clinically significant unstable medical disorder, lifethreatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure
12. Patient tested COVID positive within last 30 days of screening
13. Patient tested COVID positive within 48 hours within procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<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> 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>