A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of an Investigational Dural Sealant Used in Cranial Procedures

The purpose of this study is to evaluate whether or not an investigational dural sealant can be used safely and effectively to help seal the dura mater after cranial (brain) surgery. The dura mater normally encloses cerebrospinal fluid (CSF), which bathes the brain tissue. After cranial surgery, the dura is stitched together; however, CSF may still leak through small stitch holes. The investigational dural sealant will be used to stop CSF leaks along with standard of care methods to close the dura tissue at the end of the surgical procedure. In this study, the investigational dural sealant system will be compared to the FDA-approved DuraSeal Dural Sealant System. One of the goals of this study is to see if the investigational dural sealant system performs as well as the DuraSeal Dural Sealant System.

You may be eligible to participate in this study if you:

• Are between 18 and 75 years of age
• Are scheduled for an elective cranial procedure involving a dural incision
• Are able and willing to provide informed consent
• Are able and willing to meet study requirements, including attending all post-operative study visits and radiological tests

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.