At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 256 enrolled
Drug / intervention
Bioseal Fibrin Sealant +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery
In Brief
A Phase 4 clinical trial evaluating Bioseal Fibrin Sealant and Standard of Care (SoC) for Hemostasis and Meningioma Surgery. Completed, enrolled 256 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis, Meningioma Surgery
CountriesChina
CollaboratorsGuangzhou Bioseal Biotechnology Co., Ltd.
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedJan 2014
Primary CompletionAug 2014
Study CompletionSep 2014
TodayJul 2026
First PostedJan 14, 2014
Enrollment StartNov 1, 2013
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.5 years ago
Interventions
Bioseal Fibrin Sealantbiological
Standard of Care (SoC)other