Phase 2
Completed N=214
The EVICEL® Gastrointestinal Study
Source: ClinicalTrials.gov NCT01589822 ↗Enrolled (actual)
214
Serious AEs
26.6%
Results posted
Feb 2015
Primary outcomePrimary: Absence of Gastrointestinal (GI) Leak — 72; 81; 38 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Gastrointestinal (GI) Leak |
72; 81; 38 | — |
| SECONDARY Incidence of Adverse Events |
633; 735; 347 | — |
| SECONDARY Incidence of GI Leak |
9; 6; 3 | — |
| SECONDARY Incidence of Stricture |
2; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects undergoing primary elective GI surgery
- Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures
Exclusion Criteria
- Avastin use within 30 days prior to surgery;
- Known hypersensitivity to the human blood products or the components of the investigational product;
- Female subjects who are pregnant or nursing;
- Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
Data sourced from ClinicalTrials.gov (NCT01589822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.