NCT02046278已完成不适用
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 9
- 主要终点
- Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
研究概览
简要总结
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, or authorized representative, signed a written Informed Consent Form
- •Subject is 18 years or older
- •Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- •If female - not be of child bearing potential, or be using acceptable contraception methods.
- •Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
排除标准
- •Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- •Subject participating in any other study involving an investigational (unapproved) drug or device.
- •Subject with a BMI higher than 40
- •Female Subject states that she is pregnant or breast feeding
- •Subject with ASA status higher than 3
- •Avastin use within 30 days prior to surgery
- •Subject who underwent a prior pelvic anastomosis
- •Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
结局指标
主要结局
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
时间窗: Up to 15 weeks
次要结局
- Performance Rate of anastomotic leak (both radiological and clinical leaks)(Up to 15 weeks post procedure or at stoma closure, whichever comes first)
研究者
研究点 (9)
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