At a glance
ClinicalIndex Comparison RecordN/ACompleted· 300 enrolled
Drug / intervention
EVICEL ™ Fibrin Sealant (Human)biological
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, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
In Brief
An observational study evaluating EVICEL ™ Fibrin Sealant (Human) for Peripheral Vascular Disease and Hemorrhage. Completed, enrolled 300 participants across 2 sites.
Detailed Summary
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Disease, Hemorrhage
CountriesUnited States
CollaboratorsOMRIX Biopharmaceuticals
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJul 2010
Primary CompletionApr 2014
Study CompletionMay 2014
TodayJul 2026
First PostedJul 8, 2010
Enrollment StartJun 1, 2010
Primary CompletionApr 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.0 years ago
Interventions
EVICEL ™ Fibrin Sealant (Human)biological
Commercial Evicel