A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 12
- 主要终点
- Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
研究概览
简要总结
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
详细描述
A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (age ≥ 22 years) as required by local law
- •Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
- •Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
- •The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form
排除标准
- •Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
- •Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
- •Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
- •Non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.
- •Female subjects pregnant at the time of the surgical procedure.
- •Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
- •Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- •Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
结局指标
主要结局
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
时间窗: During surgical procedure
The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
时间窗: 30 days
Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient
次要结局
- Secondary Endpoint - Disease-free Survival(5 years)
- Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.(30 days)
- Secondary Endpoint - Operative Time (Min)(up to 720 minutes)
- Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).(intraoperative)
- Secondary Endpoint - Transfusion Rate Through 30 Days.(30 days)
- Secondary Endpoint - Rate of Device-related Conversions(intraoperative)
- Secondary Endpoint - Hospital Length of Stay (Days)(30 days)
- Secondary Endpoint - Readmission Rate (Through 30 Days)(30 days)
- Secondary Endpoint - Reoperation Rate (Through 30 Days).(30 days)
- Secondary Endpoint - Mortality Rate (Through 30 Days).(30 days)
- Secondary Endpoint - Progression-free Survival(5 years)
- Secondary Endpoint - Disease-free Survival(5 years)
- Secondary Endpoint - Overall Survival(5 years)