A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Inguinal and Ventral Hernia Repair Surgery (Enable Hernia Repair)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 14
- 主要终点
- Surgical success rate
研究概览
简要总结
A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).
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 one of the following hernia repairs: (a.) primary or incisional ventral hernia(s). Multiple small hernia defects are allowed with total distance of combined defects being < 10cm (b.) inguinal (unilateral or bilateral) hernia(s).
- •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
- •Patients for which minimally invasive surgery is contraindicated as determined by the Investigator
- •Patients with a recurrent hernia
- •Subjects with femoral hernia defects
- •Subjects with ventral hernia defect(s) located in M1, M5, or L4
- •Patients with emergent hernia repair
- •Ventral hernia is CDC (Center for Disease Control) grade 2 or higher
- •Use of component separation techniques to close the hernia defect
- •Inability to close the hernia defect
- •Hernia defect is ≥ 10 cm
- •Patient has BMI > 40
- •Patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
- •Patients diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
- •Female patients pregnant at the time of the surgical procedure.
- •Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
- •Patients who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- •Patients with active infections including but not limited to pneumonia, urinary tract infection, cellulitis, or bacteremia
研究组 & 干预措施
Robotic-Assisted Surgery (RAS) Hernia Repair Surgery
Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system
干预措施: Robotic-Assisted Surgery (RAS) Hernia Repair Surgery (Device)
结局指标
主要结局
Surgical success rate
时间窗: 2 Years
Rate of conversions from Hugo™ System to laparoscopic, open surgery, or use of an alternative robotic-assisted system.
Surgical site event rate
时间窗: 2 Years
The primary safety endpoint is the overall rate of subjects with one or more procedure- and/or device-related surgical site events (SSEs), from the first incision through 30 days post-procedure. SSE is defined as the following complications: * Surgical-site occurrence (SSO): Bleeding, Hemorrhage: Requiring transfusion; Bowel Injury; Bowel Obstruction; Cellulitis; Epigastric Vessel Injury; Symptomatic Hematoma: Requiring procedural intervention; Symptomatic Seroma: Requiring procedural intervention; Symptomatic Edema: Requiring procedural intervention * Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)
Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success
时间窗: During surgical procedure, over an average of 81 minutes
The primary effectiveness endpoint is rate of subjects who have surgical success, with surgical success defined as the procedure not going into conversion. Conversion is defined as the switch from the robotic-assisted approach using the Hugo™ RAS system to laparoscopic, open surgery, or use of an alternative robotic-assisted system.
Primary Safety Endpoint - Rate of Subjects With Surgical Site Event
时间窗: 30 Days
The primary safety endpoint is the overall rate of subjects with one or more procedure- and/or device-related surgical site events (SSEs), from the first incision through 30 days post-procedure. SSE is defined as the following complications: * Surgical-site occurrence (SSO): Bleeding, Hemorrhage: Requiring transfusion; Bowel Injury; Bowel Obstruction; Cellulitis; Epigastric Vessel Injury; Symptomatic Hematoma: Requiring procedural intervention; Symptomatic Seroma: Requiring procedural intervention; Symptomatic Edema: Requiring procedural intervention * Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)
次要结局
- Operative time(Intraoperative)
- Readmission rate through 30 days post-procedure(30 Days)
- Recurrence rate through 2 years post-procedure(2 Years)
- Complication rate(30 Days)
- Major Complication Rate(30 Days)
- Reoperation rate through 30 days post-procedure(30 Days)
- Recurrence rate through 30 days post-procedure(30 Days)
- Secondary Endpoint - Rate of Subjects With Complications(30 Days)
- Secondary Endpoint - Rate of Subjects With Major Complications(30 Days)
- Secondary Endpoint - Operative Time(Intraoperative)
- Secondary Endpoint - Rate of Subjects With Readmission(30 Days)
- Secondary Endpoint - Rate of Subjects With Reoperation(30 Days)
- Secondary Endpoint - Rate of Subjects With Recurrence(30 Days)
- Secondary Endpoint - Rate of Subjects With Recurrence Through 2 Years Post-procedure(2 Years)