Phase IV Bioseal Study in Brain Tumor Surgery

Phase 4

Completed

Interventions: Other: Standard of Care (SoC)
Biological: Bioseal Fibrin Sealant

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Standard of Care (SoC)	Standard of Care (SoC)	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.
Bioseal Fibrin Sealant	Bioseal Fibrin Sealant	A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Primary Outcome Measures

Name	Time	Method
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.	Intra-operative, 6 minutes following randomization	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.

Secondary Outcome Measures

Name	Time	Method
Hemostasis at the TBS at 3 Minutes Following Treatment Application	Intra-operative, 3 minutes following randomization	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.
Incidence of Potential Bleeding-related Adverse Events	Through 30-day follow-up
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.	Through 30-day follow-up

Locations (7): Clinical Investigation Site #5
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Changsha, Hunan, China
Clinical Investigation Site #4
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Hangzhou, Zhejiang, China
Clinical Investigation Site #7
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Beijing, China
Clinical Investigation Site #2
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Shanghai, China
Clinical Investigation Site #1
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Tianjin, China
Clinical Investigation Site #6
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Zhengzhou, Henan, China
Clinical Investigation Site #3
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Chengdu, Sichuan, China