NCT01241565已完成不适用
A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Incidence of Prolonged Air Leaks
研究概览
简要总结
The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be 18 years of age or older.
- •The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer.
- •The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure.
- •The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent.
排除标准
- •The subject is pregnant or breastfeeding.
- •The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease.
- •A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary.
- •The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected.
- •The subject is scheduled to receive intra-operative brachytherapy.
- •The subject has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months.
- •Re-operative surgery is excluded if it is on the same side as the previous surgery.
- •Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
- •The subject is unable to comply with the follow-up visit schedule
结局指标
主要结局
Incidence of Prolonged Air Leaks
时间窗: Day 30
Defined as \> 5 days by the Society for Thoracic Surgery
次要结局
- Duration of Chest Tube Following Surgery(Approximately Day 5)
- Incidence of Serosal Tearing(Day 30)
- Incidence of Air Leaks(Day 30)
- Duration of Air Leak(Day 30)
- Length of Hospital Stay(Approximately Day 6)
研究者
研究点 (6)
Loading locations...
相似试验
撤回
不适用
Duet TRS Used in Pulmonary ResectionsLung CancerNCT01026025Medtronic - MITG
终止
1 期
The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic OriginCOVID-19NCT04601077Nitric Oxide Innovations LLC524
撤回
不适用
iNod™ Ultrasound-Guided Needle Biopsy System StudyMultiple Pulmonary NodulesBiopsy, Fine-NeedleSolitary Pulmonary NoduleNCT05804435Boston Scientific Corporation
已完成
不适用
Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux DiseaseGERDNCT00587522NDO Surgical, Inc.64
撤回
不适用
Monopolar and Bipolar in Esophageal ESDEsophageal NeoplasmEsophageal PolypEndoscopic Submucosal DissectionBipolar ElectocauteryNCT05736705Baylor College of Medicine