NCT02338583已完成不适用
A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China
Ethicon Endo-Surgery3 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 3
- 主要终点
- Occurrence of prolonged air leaks
研究概览
简要总结
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled.
Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- •Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- •ASA score < 3;
- •No prior history of VATS or open lung surgery;
- •Willing to give consent and comply with study-related evaluation and treatment schedule; and
- •At least 18 years of age.
排除标准
- •Subjects satisfying the following criteria will be eligible for participation in this study:
- •Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- •Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- •ASA score < 3;
- •No prior history of VATS or open lung surgery;
- •Willing to give consent and comply with study-related evaluation and treatment schedule; and
- •At least 18 years of age.
结局指标
主要结局
Occurrence of prolonged air leaks
时间窗: 30 days
次要结局
- 5.Time to chest tube removal(30 days)
- 2.Occurrence of postoperative air leaks(30 days)
- Length of stay (LOS)(30 days)
- Volume of estimated intra-operative blood loss(Intra-operative)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUSBariatric - Sleeve Gastrectomy Staple Line ReinforcementGynecology - Vaginal Cuff ClosureNCT03937011Ethicon, Inc.161
已完成
不适用
Observational Study of Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound DressingWoundsNCT02662218BSN Medical GmbH32
进行中（未招募）
不适用
Clinical Investigation of the da Vinci Surgical SystemThymomaMediastinal TumorGynecologic DiseaseGynecologic CancerPelvic Organ ProlapseProstate DiseaseVentral HerniaObesity, MorbidProstate CancerInguinal HerniaNCT05682742Intuitive Surgical53
进行中（未招募）
不适用
To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes MellitusDiabetes Mellitus, Type 2NCT05926414Daewoong Pharmaceutical Co. LTD.15,000
终止
不适用
Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS ProcedureAtrial FibrillationNCT00415558Maquet Cardiovascular