Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
256 participants
INTERVENTIONAL
2013-11-01
2014-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Standard of Care (SoC)
Bioseal Fibrin Sealant
A porcine-derived fibrin sealant consisting of thrombin and fibrinogen
Bioseal Fibrin Sealant
Interventions
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Bioseal Fibrin Sealant
Standard of Care (SoC)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Guangzhou Bioseal Biotechnology Co., Ltd.
INDUSTRY
Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Kocharian, MD, PhD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Clinical Investigation Site #6
Zhengzhou, Henan, China
Clinical Investigation Site #5
Changsha, Hunan, China
Clinical Investigation Site #3
Chengdu, Sichuan, China
Clinical Investigation Site #4
Hangzhou, Zhejiang, China
Clinical Investigation Site #7
Beijing, , China
Clinical Investigation Site #2
Shanghai, , China
Clinical Investigation Site #1
Tianjin, , China
Countries
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Other Identifiers
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BIOS-13-002
Identifier Type: -
Identifier Source: org_study_id
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