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Phase IV Bioseal Study in Brain Tumor Surgery

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 14, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Guangzhou Bioseal Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Ethicon, Inc.
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.

Condition Intervention Phase
Hemostasis Meningioma Surgery Biological: Bioseal Fibrin Sealant Other: Standard of Care (SoC) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery

Resource links provided by NLM:

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Hemostasis at the TBS at 6 minutes following treatment application. Hemostasis is defined as no detectable bleeding at the TBS. [ Time Frame: Intra-operative ]

Secondary Outcome Measures:
  • Hemostasis at the TBS at 3 minutes following treatment application [ Time Frame: Intra-operative ]
  • 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 ]

Enrollment: 256
Study Start Date: November 2013
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard of Care (SoC)
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034799

China, Henan
Clinical Investigation Site #6
Zhengzhou, Henan, China, 450052
China, Hunan
Clinical Investigation Site #5
Changsha, Hunan, China, 410008
China, Sichuan
Clinical Investigation Site #3
Chengdu, Sichuan, China, 610041
China, Zhejiang
Clinical Investigation Site #4
Hangzhou, Zhejiang, China, 310009
Clinical Investigation Site #7
Beijing, China, 100048
Clinical Investigation Site #2
Shanghai, China, 200040
Clinical Investigation Site #1
Tianjin, China, 300052
Sponsors and Collaborators
Ethicon, Inc.
Guangzhou Bioseal Biotechnology Co., Ltd.
Study Director: Richard Kocharian, MD, PhD Ethicon, Inc.
  More Information

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT02034799     History of Changes
Other Study ID Numbers: BIOS-13-002
First Submitted: January 10, 2014
First Posted: January 14, 2014
Last Update Posted: October 12, 2017
Last Verified: March 2015

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Fibrin Tissue Adhesive