NCT01790230已完成不适用
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of subject's safety by incidence of related Adverse Events
研究概览
简要总结
A preliminary Study in Subjects Undergoing Low Anterior Resection
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 —（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
- •Subject is at least 18 years of age
- •Subject is scheduled for elective open resection
- •Stapled anastomosis created within 10cm of the anal verge
- •Subject is willing to comply with the follow-up requirements of the study
排除标准
- •Subject has a history of hypersensitivity to porcine derived gelatin or collagen
- •Subject has unacceptable baseline hematological results
- •Subject on chronic preoperative treatment with steroids and anticoagulants
- •Subject with elevated liver function tests
- •Subject with abnormal kidney function
- •Subject with a BMI higher than 35
- •Subject participating in any other study for either drug or device which can influence collection of valid data under this study
- •Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
- •Anastomosis was performed differently from what was defined
- •Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
- •Subject has intraoperative bleeding in excess of 500cc
- •Subject has peritoneal carcinomatosis
结局指标
主要结局
Assessment of subject's safety by incidence of related Adverse Events
时间窗: Approx. 1 month
次要结局
- Assessment of the device's application technique(Intra-operative)
研究者
研究点 (2)
Loading locations...
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