Phase IV Bioseal Study in Brain Tumor Surgery

• ClinicalTrials.gov Identifier: NCT02034799
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Results First Posted: February 26, 2018
• Last Update Posted: February 26, 2018
• Sponsor: Ethicon, Inc.
• Collaborator: Guangzhou Bioseal Biotechnology Co., Ltd.
• Information provided by (Responsible Party): Ethicon, Inc.

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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. [ Time Frame: Intra-operative, 6 minutes following randomization ]
   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.

Secondary Outcome Measures :

1. Hemostasis at the TBS at 3 Minutes Following Treatment Application [ Time Frame: Intra-operative, 3 minutes following randomization ]
   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.
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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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.

Contacts and Locations

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

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT02034799
• Other Study ID Numbers: BIOS-13-002
• First Posted: January 14, 2014
• Results First Posted: February 26, 2018
• Last Update Posted: February 26, 2018
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Meningioma; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Fibrin Tissue Adhesive; Hemostatics; Coagulants