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Phase IV Bioseal Study in Brain Tumor Surgery

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ClinicalTrials.gov Identifier: NCT02034799
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 9, 2015
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
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
Study Start Date : November 2013
Primary Completion Date : August 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Hemostasis at the TBS at 3 minutes following treatment application [ Time Frame: Intra-operative ]
  2. Incidence of neurosurgical complications, central nervous system events and surgical wound complications. [ Time Frame: Through 30-day follow-up ]
  3. Incidence of potential bleeding-related adverse events [ Time Frame: Through 30-day follow-up ]

Eligibility Criteria

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 Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 9, 2015
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