Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Meningioma

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Coagulants

All Drugs and Chemicals

Hemostatics

Thrombin

Fibrin Tissue Adhesive

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.

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Bioseal Fibrin Sealant

Standard of Care (SoC)

Richard Kocharian, MD, PhD

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.

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

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.

Guangzhou Bioseal Biotechnology Co., Ltd.

Ethicon, Inc.

Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.

Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH). Standard of Care (SoC)

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Bioseal Fibrin Sealant

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Height

Weight

Underweight

Normal

Overweight

Obese

BMI Group

Current Smoker

Former Smoker

Never Smoked

Smoking Status

Adult subjects between the ages of 18 and 75 years were eligible for recruitment into the study.Subject 16225 was enrolled at age 12 and did not match the study inclusion/exclusion criteria. This was logged as a protocol deviation.

Senior Director of Ethicon Clinical R&D

H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application

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

Hemostasis at the TBS at 3 Minutes Following Treatment Application

Neurosurgical Complication

Unplanned Intervention

Central Nervous System

Surgical Wound Complication

Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.

Incidence of Potential Bleeding-related Adverse Events

SoC include Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).

Overall Study

Spots Global Cancer Trial Database for Phase IV Bioseal Study in Brain Tumor Surgery

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial