CTRI/2012/10/003075尚未招募4 期
Open-label,Multicentre, Observational, Prospective, Real-time data capturing of Usage, Outcome & Physician satisfaction of Coseal in Cardio-Vascular-Thoracic Operative and Re-operative procedures - Coseal Registry
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Patients undergoing cardiovascular and thoracic surgery who require use of Coseal as a treatment strategy.
- •2.Patient undergoing open, Video Assisted surgery and robotic surgery to be included and analysed as subgroups
- •3.Written informed consent obtained from the patient or legal representative for data collection post surgery in patients who had Coseal used intraoperatively (data privacy laws).
排除标准
- •1.Known hypersensitivity to components of the investigational product
- •2.Known Immune system disorders, immunodeficiency
- •3.Concomitant use of any other anti-adhesion product
- •4.Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
- •5.Unplanned re-operation in case of use for anti-adhesion
- •6.Contraindications for use of Coseal
研究者
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