The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.

Inclusion Criteria:

• Subjects between 18 and 75 years of age
• Undergoing elective meningioma surgery and having a tumor cavity
• Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis
• Able and willing to comply with procedures required by protocol
• Signed and dated written informed consent prior to any study related procedures.

Exclusion Criteria:

• Subjects undergoing emergency surgery
• Subjects with any intra-operative findings that may preclude conducting of the study procedures
• Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the Target Bleeding Site (TBS)
• Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products
• Subjects who have a history of traumatic head injury
• Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period
• The subject, in the opinion of the investigator, would not be suitable for participation in the study
• Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Adult subjects between the ages of 18 and 75 years were eligible for recruitment into the study.Subject 16225 was enrolled at age 12 and did not match the study inclusion/exclusion criteria. This was logged as a protocol deviation.

Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.