Phase IV Bioseal Study in Brain Tumor Surgery

This study has been completed.
Sponsor:
Collaborator:
Guangzhou Bioseal Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT02034799
First received: January 10, 2014
Last updated: April 8, 2015
Last verified: March 2015
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemostasis at the TBS at 3 minutes following treatment application [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Incidence of neurosurgical complications, central nervous system events and surgical wound complications. [ Time Frame: Through 30-day follow-up ] [ Designated as safety issue: Yes ]
  • Incidence of potential bleeding-related adverse events [ Time Frame: Through 30-day follow-up ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034799

Locations
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
China
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.
Investigators
Study Director: Richard Kocharian, MD, PhD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT02034799     History of Changes
Other Study ID Numbers: BIOS-13-002
Study First Received: January 10, 2014
Last Updated: April 8, 2015
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Meningioma
Central Nervous System Neoplasms
Meningeal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Nervous System Diseases
Nervous System Neoplasms
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015