CTRI/2022/09/045789尚未招募2 期
Prospective Clinical Study to Evaluate the Safety and Efficacy of theVersius Surgical System in Robot-Assisted Hysterectomy
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
- 2 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 total laparoscopic hysterectomy
- •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. Female, aged 18 years or above
- •4. Female of childbearing potential, must not be pregnant
- •5. Patients with BMI ââ?°Â¤40. Ideally BMI ââ?°Â¥25 to ââ?°Â¤ 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)
- •Class IV or above (Appendix B)
- •5. Uterus size of > 14 weeks
- •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
- •10. Patient tested COVID positive within last 30 days of screening
- •11. Patient tested COVID positive within 48 hours within procedure
- •12. Diabetes mellitus (Glycemia > 11mmol/L; >200 mg/dL)
- •13. Uncontrolled hypertension
研究者
相似试验
尚未招募
4 期
Versius Clinical StudyCTRI/2022/08/045073CMR Surgical India Pvt Ltd
进行中（未招募）
2 期
Versius clinical study to evaluate the safety and performance of the Versius Surgical Robotic SystemRobotically assisted surgery in patients requiring general, gynaecological, urological and colorectal surgical and minimal access proceduresSurgeryISRCTN74522039CMR Surgical (United Kingdom)645
进行中（未招募）
2 期
Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted cholecystectomy (a surgical procedure to remove your gallbladder)Robot assisted cholecystectomySurgeryISRCTN17254664CMR Surgical (United Kingdom)30
进行中（未招募）
2 期
Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted cholecystectomy (a surgical procedure to remove your gallbladder)ISRCTN48886202CMR Surgical (United Kingdom)30
进行中（未招募）
2 期
Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy (a surgical procedure to remove your womb)Robot assisted total hysterectomySurgeryISRCTN11414606CMR Surgical (United Kingdom)30