A PROSPECTIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF THE VERSIUS SURGICAL ROBOTIC SYSTEM
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Rate of unplanned conversion of procedures to other MAS or open surgery
研究概览
简要总结
STUDY TITLE: A prospective clinical study to evaluate the safety and performance of the Versius Surgical Robotic System
OBJECTIVE: To evaluate the safe use and performance of the Versius Surgical Robotic System in robotically-assisted surgery across multiple surgical procedures
STUDY DESIGN: A prospective cohort study in line with the Stage 2a and 2b IDEAL collaboration recommendations:
Stage 2a IDEAL: 30 patients Stage 2b IDEAL: 240 patients
PRODUCT: The Versius Surgical Robotic System (Versius)
DEVICE RISK Medical Device Regulations: Class IIb CLASSIFICATION: US FDA: Class II General Controls
STUDY POPULATION: All patients suitable for at least one of the minimal access surgery (MAS) listed below using Versius (as determined by the Principal Investigator), aged between 18 to 65 years old
PROCEDURE TYPES: Minimal access surgical procedures listed below:
Stage 2a IDEAL: minor gynaecological surgical procedures from salpingectomy (unilateral or bilateral), salpingo-oophorectomy, unilateral or bilateral oophorectomy, and ovarian cystectomy for benign disease and minor general surgical procedure appendectomy
Stage 2b IDEAL: gynaecological surgical procedure: total laparoscopic hysterectomy +/- unilateral or bilateral salpingo-oophorectomy and general surgical procedure: cholecystectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient deemed suitable for at least one of the surgical procedures using Versius
- •Patients (or appropriate legal representatives) able to provide written and audio-visual informed consent to participate in the study
- •Male or female, aged between 18 and 65 years old
- •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
- •Patient participation in an investigational clinical study within 30 days before screening
- •Inability to provide informed consent
- •Uncontrolled hypertension and/or diabetes mellitus
- •Patients who fall into New York Heart Association (NYHA) Class III or IV (Appendix B)
- •Incidence of metastases, regional and/or distant
- •History of chronic alcohol or drug abuse
- •Chronic renal failure or on dialysis
- •Significant medical history or immunocompromised
- •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.
结局指标
主要结局
Rate of unplanned conversion of procedures to other MAS or open surgery
时间窗: Hopsitalisation Visit
次要结局
- The following parameters will be collected during the study:(Operative time – from incision to skin closure)