Title
Phase IV Bioseal Study in Brain Tumor Surgery
A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery
Phase
Phase 4Lead Sponsor
EthiconStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hemostasis Meningioma SurgeryIntervention/Treatment
human fibrin ...Study Participants
256The 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.
A porcine-derived fibrin sealant consisting of thrombin and fibrinogen
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.
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.
| Event Type | Organ System | Event Term | Standard of Care (SoC) | Bioseal Fibrin Sealant |
|---|
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.
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.
