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 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.

Study Overview

• Status: Completed
• Conditions: Hemostasis; Meningioma Surgery
• Intervention / Treatment: Other: Standard of Care (SoC); Biological: Bioseal Fibrin Sealant

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100048
    • Clinical Investigation Site #7
  • Shanghai, China, 200040
    • Clinical Investigation Site #2
  • Tianjin, China, 300052
    • Clinical Investigation Site #1
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Clinical Investigation Site #6
  • Hunan
    • Changsha, Hunan, China, 410008
      • Clinical Investigation Site #5
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Clinical Investigation Site #3
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Clinical Investigation Site #4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Standard of Care (SoC)
Experimental: Bioseal Fibrin Sealant; A porcine-derived fibrin sealant consisting of thrombin and fibrinogen	Biological: Bioseal Fibrin Sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following 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 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.	Intra-operative, 6 minutes following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis at the TBS at 3 Minutes Following Treatment Application	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.	Intra-operative, 3 minutes following randomization
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.		Through 30-day follow-up
Incidence of Potential Bleeding-related Adverse Events		Through 30-day follow-up

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Collaborators: Guangzhou Bioseal Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Meningioma; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: BIOS-13-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No