Phase IV Bioseal Study in Brain Tumor Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery

Conditions
-----------------
Hemostasis, Meningioma Surgery

Intervention / Treatment
-----------------
* Biological: Bioseal Fibrin Sealant
* Other: Standard of Care (SoC)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care (SoC)<br>Standard of Care (SoC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants. | Other: Standard of Care (SoC)<br> <br> |
| Experimental: Bioseal Fibrin Sealant<br>A porcine-derived fibrin sealant consisting of thrombin and fibrinogen | Biological: Bioseal Fibrin Sealant<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. | The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS. | Intra-operative, 6 minutes following randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis at the TBS at 3 Minutes Following Treatment Application | The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS. | Intra-operative, 3 minutes following randomization | 
| Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. |  | Through 30-day follow-up | 
| Incidence of Potential Bleeding-related Adverse Events |  | Through 30-day follow-up |