An 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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Cardio Vascular Outcome
研究概览
简要总结
This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage, Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re- Operative procedures.
Objective of this study is to assess current practice pattern and best practice sharing of usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post surgical adhesion enforcement of suture lines in lung resection procedures (3) From this data to document and generate a real life experience on the use of Coseal in cardio vascular and thoracic surgery.
Number of expected patient enrollment is 750 from 20 participating sites.
详细描述
Objectives:
- Assessing current practice pattern and best practice sharing of usage of Coseal as per IFU by collecting data on oSealing suture lines along arterial and venous reconstructions oPatients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post surgical adhesion enforcement of suture and staple lines in lung resection procedures
- From this data to document and generate a real life experience on the use of Coseal in cardio vascular and thoracic surgery
- To possibly create a guideline for usage of Sealant in routine practice in India
- To study delivery methods and clinical impact in minimally invasive surgery like VATS and robotic surgery
End points
Primary Endpoint
- Cardio vascular sealing:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiovascular and thoracic surgery who require use of Coseal as a treatment strategy.
- •Patient undergoing open, Video Assisted surgery and robotic surgery to be included and analysed as subgroups
- •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
- •Known hypersensitivity to components of the investigational product
- •Known Immune system disorders, immunodeficiency
- •Concomitant use of any other anti-adhesion product
- •Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
- •Unplanned re-operation in case of use for anti-adhesion
- •Contraindications for use of Coseal
结局指标
主要结局
Cardio Vascular Outcome
时间窗: 18 months
To report the effectiveness and safety of COSEAL in the control of anastomotic suture line and needle hole suture bleeding during vascular reconstruction by checking the incidence of immediate anastomotic sealing and the presence of persistent intra-operative and postoperative bleeding
次要结局
- Cardiovascular (sealing and adhesion prevention):(18 months)
- Thoracic and Lung (Sealing and Adhesion prevention)(18 months)
研究者
Dr. Ali Zamir Khan
Head of Department, Minimally Invasive & Robotic Thoracic Surgery
Medanta, The Medicity, India