A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy 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
- 32
- 试验地点
- 10
- 主要终点
- Rate of Conversion
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 pulmonary lobectomy, and in thymectomy procedures.
详细描述
Primary performance:
The primary endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted thoracic procedure without conversion to an alternate approach. Conversion to an alternate approach comprises undocking of the da Vinci SP to complete the planned procedures using other methods, such as open, VATS, or multiport robotic (da Vinci SI or X/Xi)
Primary Safety:
The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years
- •Willing and able to provide a written informed consent
- •Willing and able to comply with the study protocol requirements including follow-up examinations at 14 days and 30 days post-operatively, and post-market long term follow-up on an annual basis through 5 years
- •Lobectomy Inclusion Criteria:
- •- Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter
- •Thymectomy Inclusion Criteria:
- •- Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter
排除标准
- •Clinical or radiological evidence of mediastinal or systemic metastatic disease
- •Life expectancy < 6 months
- •Subject with a known bleeding or clotting disorder
- •Subjects actively receiving therapeutic-dose anticoagulation or anti-platelet medications at the time of operation
- •Uncontrolled systemic illness 6 months prior to planned surgical procedure 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
- •Previous chemotherapy, immunotherapy and/or radiation therapy for treatment of the cancer to be resected
- •Subject has a contraindication for general anesthesia or surgery
- •Subjects under active immunomodulatory or immunosuppressive regimen (e.g. transplant patient, high-dose steroid requirement) within 30 days prior to the planned surgical procedure. For myasthenia patients, if steroids are weaned down to prednisone ≤ 5 mg/day prior to day of surgery, the patient may be enrolled
- •Previous sternotomy
- •Subject belongs to vulnerable population
- •Subject is pregnant or suspected to be pregnant or breastfeeding
- •Lobectomy Exclusion Criteria:
- •Tumor involving carina or any airway requiring sleeve resection, bronchoplasty
- •Tumor requiring resection of local structures (e.g. chest wall) or extended resection such as bilobectomy
- •History of pulmonary hypertension
- •Previous ipsilateral thoracic surgery or radiotherapy
- •Thymectomy Exclusion Criteria:
- •Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery
- •Tumor requiring resection of local structures (except pericardium)
- •Confirmed thymic carcinoma
- •Intraoperative Exclusion Criteria:
- •- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
研究组 & 干预措施
SP Surgical System- Lobectomy procedures
Pulmonary lobectomy performed by da Vinci SP Surgical System.
干预措施: Robotic-Assisted Surgery (Device)
SP Surgical System - Thymectomy
Thymectomy procedures performed by the da Vinci SP Surgical System
干预措施: Robotic-Assisted Surgery (Device)
结局指标
主要结局
Rate of Conversion
时间窗: Intra-operative period
Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
Major Adverse Event Rate
时间窗: Intra-operative through the 30 days follow-up period
Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Rate of Conversion
时间窗: Intra-operative period
Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
次要结局
未报告次要终点