Phase IV Bioseal Study in Brain Tumor Surgery

Hemostasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034799
• Other study ID #: BIOS-13-002
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2014
• Last updated: August 17, 2017
• Start date: November 1, 2013
• Est. completion date: September 1, 2014

Study information

• Verified date: August 2017
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: September 1, 2014
• Est. primary completion date: August 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Hemostasis
• Meningioma
• Meningioma Surgery

Intervention

Biological:
• Bioseal Fibrin Sealant

Other:
• Standard of Care (SoC)

Locations

Country	Name	City	State
China	Clinical Investigation Site #7	Beijing
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 #2	Shanghai
China	Clinical Investigation Site #1	Tianjin
China	Clinical Investigation Site #6	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	Guangzhou Bioseal Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.	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.	Intra-operative, 6 minutes following randomization
Secondary	Hemostasis at the TBS at 3 Minutes Following Treatment Application	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.	Intra-operative, 3 minutes following randomization
Secondary	Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.		Through 30-day follow-up
Secondary	Incidence of Potential Bleeding-related Adverse Events		Through 30-day follow-up