At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 234 enrolled
Drug / intervention
EVICEL 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 Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
In Brief
A Phase 3 clinical trial evaluating EVICEL Fibrin Sealant and Hydrogel sealant for Cerebrospinal Fluid Leak. Completed, enrolled 234 participants across 26 sites in 6 countries.
Detailed Summary
The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrospinal Fluid Leak
CountriesAustralia, Belgium, Canada, New Zealand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJul 2015
Primary CompletionSep 2017
Study CompletionOct 2017
TodayJul 2026
First PostedMay 29, 2015
Enrollment StartJul 1, 2015
Primary CompletionSep 13, 2017
Study CompletionOct 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.1 years ago
Interventions
EVICEL Fibrin Sealantbiological
Hydrogel sealantdevice