NL-OMON42234已完成4 期
A post-market study of the Endo GIA* Reinforced Reload with Tri-Staple* Technology - Reinforced Reload Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. The subject must be 18-80 years of age
- •2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
- •3. The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA* Reload with Tri-Staple* Technology device will be used per its Instructions For Use
- •-For Thoracic procedures, these may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures (not in The Netherlands)
- •-For Abdominal procedures, these may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection
- •4. For thoracic subjects: the subject has a FEV1 *40% (Not in The Netherlands)
排除标准
- •Subjects undergoing cardiac and vascular procedures
- •2. The procedure is an emergency procedure
- •3. The procedure is a revision/reoperation for the same indication
- •4. Any female subject who is pregnant. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)
- •6. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
- •7. The subject is unable or unwilling to comply with the study requirements or follow-up schedule
- •8. The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
- •9. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment.
- •10. The subject is concurrently enrolled in another investigational drug or device research study
研究者
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