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The EVICEL® Neurosurgery Phase III Study

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
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Cerebrospinal Fluid Leak
  • Cerebrospinal Fluid Drainage

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
Neck pain
4%
Pneumonia
4%
Tachycardia
4%
Postoperative wound infection
4%
Dizziness
4%
Chest pain
4%
Fatigue
3%
Pyrexia
3%
Convulsion
3%
Cerebrospinal fluid leakage
2%
Brain neoplasm
2%
Glioblastoma
2%
Pseudomeningocele
1%
Post procedural haemorrhage
1%
Malignant melanoma
1%
Cerebral infarction
1%
Hydrocephalus
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~22 spots leftby Dec 2025
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