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

Ethicon, Inc.7 sites in 1 country256 target enrollmentNovember 1, 2013

ConditionsHemostasis Meningioma Surgery

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hemostasis
Sponsor: Ethicon, Inc.
Enrollment: 256
Locations: 7
Primary Endpoint: Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2013

End Date

September 1, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ethicon, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.

Time Frame: 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 Outcomes

Hemostasis at the TBS at 3 Minutes Following Treatment Application(Intra-operative, 3 minutes following randomization)
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)