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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
256
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
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.
Time frame: Intra-operative, 6 minutes following randomization
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.
Time frame: Intra-operative, 3 minutes following randomization
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
Time frame: Through 30-day follow-up
Incidence of Potential Bleeding-related Adverse Events
Time frame: Through 30-day follow-up
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Clinical Investigation Site #7
Beijing, China
Clinical Investigation Site #2
Shanghai, China
Clinical Investigation Site #1
Tianjin, China