CTRI/2022/08/045073尚未招募4 期
Prospective Clinical Study to Evaluate the Safety and Efficacy of the Versius Surgical System in Robot-Assisted Cholecystectomy
CMR Surgical India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Patient deemed suitable for laparoscopic Cholecystectomy
- •procedure using 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. Male and Female, aged 18 years or above
- •4. Female of childbearing potential, must not be pregnant and
- •agree to not become pregnant for the duration of the study
- •5. Patients with BMI <40. Priority BMI 25 to 40
排除标准
- •1. Patient participation in an investigational clinical study within 30 days before screening
- •2. Inability or difficulties to provide informed consent
- •3. Oncological cases, Patients undergoing surgery or treatment for malignant disease
- •4. Patients who fall into American Society of Anaesthesiologists (ASA) ClassIV or above
- •5. History of chronic alcohol or drug abuse
- •6. Chronic renal failure or on dialysis
- •7. Significant medical history or immunocompromised
- •8. 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
- •9. Patient tested COVID positive within last 30 days of screening
- •10.Patient tested COVID positive within 48 hours day the of the procedure
- •11.Diabetes mellitus (Glycemia > 11mmol/L ; >200 mg/dL)
- •12. Uncontrolled hypertension
研究者
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