Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy (a surgical procedure to remove your womb)
- Conditions
- SurgeryRobot-assisted total hysterectomy
- Registration Number
- ISRCTN68512297
- Lead Sponsor
- CMR Surgical (United Kingdom)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 30
1. Patient deemed suitable for total laparoscopic hysterectomy procedure using the 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. Females aged 18 years or above
4. Females of childbearing potential must not be pregnant
5. Patients with BMI =40 kg/m². Ideally BMI =25 to =40 kg/m²
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 >11 mmol/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, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure
12. Patient tested COVID positive within the last 30 days of screening
13. Patient tested COVID positive within 48 hours of the procedure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method