A prospective clinical study to evaluate the safety and performance of the Versius Surgical Robotic System

CMR Surgical (United Kingdom)0 个研究点目标入组 645 人2021年8月25日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Robotically assisted surgery in patients requiring general, gynaecological, urological and colorectal surgical and minimal access procedures
发起方: CMR Surgical (United Kingdom)
入组人数: 645
状态: 进行中（未招募）
最后更新: 4年前

暂无简介。

注册库

who.int

开始日期

2021年8月25日

结束日期

2022年7月1日

最后更新

4年前

研究类型

Interventional

性别

All

发起方

CMR Surgical (United Kingdom)

•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 (\=/\>systolic: 180 mmHg/diastolic: 120 mmHg) and/or diabetes mellitus (blood sugar level: \>200 mg/dl)
•4\. Patients who fall into American Society of Anesthesiologists (ASA) Class IV
•5\. History of chronic alcohol or drug abuse
•6\. Chronic renal failure or on dialysis
•7\. Significant medical history or immunocompromised and/or chronic use of systemic steroids
•8\. Patients undergoing surgery or treatment for malignant disease
•9\. Subjects with any other clinically significant unstable medical disorder, life\-threatening disease, or anything else in the opinion of the Investigator which would contraindicate a surgical procedure