← Back to Search

EVICEL Fibrin Sealant for Cerebrospinal Fluid Leak

Phase 3
Waitlist Available
Research Sponsored by Ethicon, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperatively, after final valsalva maneuver
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperatively through 30-day follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperatively through 30-day follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period)
Other outcome measures
Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva

Side effects data

From 2017 Phase 3 trial • 234 Patients • NCT02457546
32%
Headache
28%
Constipation
28%
Nausea
18%
Vomiting
17%
Procedural pain
11%
Hypertension
10%
Incision site pain
6%
Hyponatraemia
6%
Hemiparesis
5%
Wound secretion
5%
Hypotension
4%
Pneumonia
4%
Tachycardia
4%
Postoperative wound infection
4%
Neck pain
4%
Dizziness
4%
Chest pain
4%
Fatigue
3%
Pyrexia
3%
Convulsion
3%
Cerebrospinal fluid leakage
2%
Brain neoplasm
2%
Glioblastoma
2%
Pseudomeningocele
1%
Malignant melanoma
1%
Cerebral infarction
1%
Hydrocephalus
1%
Post procedural haemorrhage
1%
Cerebrovascular accident
1%
Sepsis
1%
Nephrolithiasis
1%
Seroma
1%
Grand mal convulsion
1%
Subgaleal haematoma
1%
Intestinal obstruction
1%
Subdural haematoma
1%
Subdural haemorrhage
1%
White blood cell count increased
1%
Non-small cell lung cancer
1%
Metastases to meninges
1%
Brain oedema
1%
Acute respiratory distress syndrome
1%
Pulmonary embolism
1%
Neutropenia
1%
Large intestine perforation
1%
Metastases to central nervous system
100%
80%
60%
40%
20%
0%
Study treatment Arm
Evicel
DuraSeal

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EVICEL Fibrin SealantExperimental Treatment1 Intervention
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
Group II: Hydrogel sealantActive Control1 Intervention
The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fibrin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Ethicon, Inc.Lead Sponsor
92 Previous Clinical Trials
61,987 Total Patients Enrolled
1 Trials studying Cerebrospinal Fluid Leak
40 Patients Enrolled for Cerebrospinal Fluid Leak
Richard Kocharian, MD, PhDStudy DirectorEthicon, Inc.
7 Previous Clinical Trials
984 Total Patients Enrolled
1 Trials studying Cerebrospinal Fluid Leak
40 Patients Enrolled for Cerebrospinal Fluid Leak
~23 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top