At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 214 enrolled
Drug / intervention
EVICEL Fibrin Sealantbiological
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 Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
In Brief
A Phase 2 clinical trial evaluating EVICEL Fibrin Sealant for Gastrointestinal Diseases. Completed, enrolled 214 participants across 22 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Diseases
CountriesAustralia, Belgium, Canada, New Zealand, South Korea, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJun 2012
Primary CompletionJan 2014
Study CompletionSep 2014
TodayJul 2026
First PostedMay 2, 2012
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.2 years ago
Interventions
EVICEL Fibrin Sealantbiological
Intraoperative