A pilot study evaluating the safety of a Novel Sternal Protection Device for cardiac surgery involving a median sternotomy incision

Protego Medical Pty Ltd0 个研究点目标入组 12 人开始时间: 2016年1月28日最近更新: 2020年1月13日

试验速览

暂无简介。

•1) Patients must be assessed as requiring cardiac surgery via a median sternotomy incision by a cardiothoracic surgeon
•2) Site personnel must obtain written informed consent from the patient prior to any study procedures (including screening procedures)

•1) Patients who require emergency cardiac surgery
•2) Patients who have undergone previous surgery via a median sternotomy incision
•3) Patients who have any significant thoracic deformity including pectus excavatum, pectus carinatum
•4) Patients where the sternal length (including the manubrium and body of the sternum and excluding the xiphisternum) is <= 130mm or => 175 mm (using an external skin preoperative measurement)
•5) Patients who weigh => 110kg
•6) Patients with a known bleeding disorder or abnormal coagulation profile
•7) Patients who have taken an anti-platelet agent (other than aspirin) or other anticoagulant within 7 days of surgery
•8) Concurrent enrolment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of cardiopulmonary bypass support
•9) Any other medical condition which in the view of the Investigator is likely to interfere with the study or put the participant at risk

发起方

Protego Medical Pty Ltd