Phase 2 N=214 Randomized Single-blind Treatment

The EVICEL® Gastrointestinal Study

Gastrointestinal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01589822 ↗

Enrolled (actual)

214

Serious AEs

26.6%

Results posted

Feb 2015

Primary outcome: Primary: Absence of Gastrointestinal (GI) Leak — 72; 81; 38 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: EVICEL Fibrin Sealant (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ethicon, Inc.
Primary completion: Jan 2014

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.