A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Performance
研究概览
简要总结
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
详细描述
Primary Performance:
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The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.
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Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance
Primary Safety:
• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures
- •Willing and able to provide a written informed consent document
- •Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years
排除标准
- •Clinical or radiological evidence of metastatic disease
- •Life expectancy less than 6 months
- •Cancer of the anal canal requiring an abdominoperineal resection
- •Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY)
- •Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
- •Subjects undergoing both LAR/TME and right colectomy during the same operation
- •Preoperative colonoscopy demonstrating synchronous colorectal cancer
- •History of inflammatory bowel disease
- •Subject has a known bleeding or clotting disorder
- •Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Subject is contraindicated for general anesthesia or surgery
- •Subject had prior incisional hernia with mesh repair
- •Subject belongs to vulnerable population
- •Subject is pregnant or suspected to be pregnant
- •Intraoperative Exclusion Criteria:
- •Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure
结局指标
主要结局
Performance
时间窗: IntraOperative period
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Adverse Events Rates
时间窗: Intraoperative through the 42-day postoperative period
Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
次要结局
未报告次要终点