ISRCTN74522039进行中（未招募）2 期
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 人开始时间: 2021年8月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 645
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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