Phase IV Bioseal Study in Brain Tumor Surgery

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 1, 2014

Interventions

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

Arms, Groups and Cohorts

  • Other: 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.
  • Experimental: Bioseal Fibrin Sealant
    • A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Hemostasis at the TBS at 3 Minutes Following Treatment Application
    • Time Frame: 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 Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
    • Time Frame: Through 30-day follow-up
  • Incidence of Potential Bleeding-related Adverse Events
    • Time Frame: Through 30-day follow-up

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ethicon, Inc.
  • Collaborator
    • Guangzhou Bioseal Biotechnology Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Kocharian, MD, PhD, Study Director, Ethicon, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.