Prospective clinical study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy

CMR Surgical (United Kingdom)0 个研究点目标入组 30 人开始时间: 2023年4月13日最近更新: 2023年4月24日

适应症

试验速览

暂无简介。

•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

发起方

CMR Surgical (United Kingdom)