At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
FS VH S/D 500 s-apr +1 moredrug
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 Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated FS VH S/D 500 S-apr (Tisseel) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.
In Brief
A Phase 3 clinical trial evaluating FS VH S/D 500 s-apr and DuraSeal Dural Sealant for Cerebrospinal Fluid Leak. Completed, enrolled 224 participants across 25 sites in 4 countries.
Detailed Summary
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrospinal Fluid Leak
CountriesCzechia, Germany, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartOct 2016
Primary CompletionAug 2018
TodayJul 2026
First PostedSep 7, 2016
Enrollment StartOct 11, 2016
Primary CompletionAug 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.8 years ago
Interventions
FS VH S/D 500 s-aprdrug
DuraSeal Dural Sealantdevice