Clinical trial NCT02034799: Phase IV Bioseal Study in Brain Tumor Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemostasis
Meningioma Surgery
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Bioseal Biotechnology Co., Ltd.
First posted: 2014-01-14
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.
timeFrame: Intra-operative, 6 minutes following randomization
Secondary outcomes:
measure: Hemostasis at the TBS at 3 Minutes Following Treatment Application
timeFrame: Intra-operative, 3 minutes following randomization
measure: Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
timeFrame: Through 30-day follow-up
measure: Incidence of Potential Bleeding-related Adverse Events
timeFrame: Through 30-day follow-up
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Clinical Investigation Site #6
state: Henan
city: Changsha
country: China
facility: Clinical Investigation Site #5
state: Hunan
city: Chengdu
country: China
facility: Clinical Investigation Site #3
state: Sichuan
city: Hangzhou
country: China
facility: Clinical Investigation Site #4
state: Zhejiang
city: Beijing
country: China
facility: Clinical Investigation Site #7
city: Shanghai
country: China
facility: Clinical Investigation Site #2
city: Tianjin
country: China
facility: Clinical Investigation Site #1
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD, PhD
role: STUDY_DIRECTOR
References: