da Vinci SP® 在结直肠手术中的研究性器械豁免研究
达芬奇 SP® 手术系统在结直肠良性和恶性疾病手术中的前瞻性、多中心研究
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.
研究概览
详细说明
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.
- 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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Florida
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Orlando、Florida、美国、32803
- Adventist Health System/Sunbelt
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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Nevada
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Las Vegas、Nevada、美国、89128
- MountianView Hospital
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital
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Texas
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Houston、Texas、美国、77030
- Houston Methodist Research Institute
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Washington
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Tacoma、Washington、美国、98405
- MultiCare - Tacoma
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-
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Dong-gu
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Ulsan、Dong-gu、韩国、25 Daehakbyeongwon-ro
- Ulsan University Hospital
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Gangseo-gu
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Seoul、Gangseo-gu、韩国、Gonghang-daero
- Ewha Womans University College of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years
- BMI ≤ 35
- Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures
- ASA ≤ 3
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：SP Lower Anterior Resection
Lower anterior resections (LAR) procedures will performed by da Vinci SP® Surgical System |
da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision |
|
其他：SP Right Colectomy
Right Colectomy (RC) procedures performed by da Vinci SP® Surgical System |
da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of Conversion
大体时间：IntraOperative period
|
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. |
IntraOperative period
|
|
Major Adverse Events Rates
大体时间：Intraoperative through the 42-day postoperative period
|
Safety defined as the incidence of all major adverse events that occur through the 42-day follow-up period |
Intraoperative through the 42-day postoperative period
|
合作者和调查者
调查人员
- 研究主任：Madhu L Gorrepati、Clinical Affairs Director
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.