Phase IV Bioseal Study in Brain Tumor Surgery

Ethicon

Status and phase: Completed; Phase 4

Conditions: Hemostasis; Meningioma Surgery

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02034799

BIOS-13-002

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

Standard of Care (SoC)

Other group

Description:

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.

Treatment:

Other: Standard of Care (SoC)

Bioseal Fibrin Sealant

Experimental group

Description:

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Treatment:

Biological: Bioseal Fibrin Sealant