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

CMR Surgical (United Kingdom)0 sites30 target enrollmentApril 13, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 13, 2023

End Date

November 1, 2023

Last Updated

3 years ago

Study Type

Interventional

Sex

Female

Sponsor

CMR Surgical (United Kingdom)

•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