Clinical Trials

To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

The purpose of this study is to assess for changes in the structure and function of the optic nerve caused by changes in cerebrospinal fluid pressure.

The objective of this study is to evaluate the efficacy of epidural blood patch (EBP) in spontaneous CSF leaks.

The purpose of this study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra-, as well as post-operative, CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.

The purpose of this study is to determine whether transverse/sigmoid sinus junction stenting reduces the risk of recurrent cerebrospinal fluid (CSF) leak in patients with idiopathic intracranial hypertension presenting with CSF leak.