A PROSPECTIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF THE VERSIUS SURGICAL ROBOTIC SYSTEM

CMR Surgical Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Patient deemed suitable for at least one of the surgical procedures using Versius
•2. Patients (or appropriate legal representatives) able to provide written and audio-visual informed consent to participate in the study
•3. Male or female, aged between 18 and 65 years old
•4. If female of childbearing potential, must not be pregnant and agree to not become pregnant for the duration of the study.

•1. Patient participation in an investigational clinical study within 30 days before screening
•2. Inability to provide informed consent
•3. Uncontrolled hypertension and/or diabetes mellitus
•4. Patients who fall into New York Heart Association (NYHA) Class III or IV (Appendix B)
•5. Incidence of metastases, regional and/or distant
•6. History of chronic alcohol or drug abuse
•7. Chronic renal failure or on dialysis
•8. Significant medical history or immunocompromised
•9. 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

发起方

CMR Surgical Limited