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The EVICEL® Neurosurgery Phase III Study

NCT02457546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2019-01-10

Study results available
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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.

Conditions

  • Cerebrospinal Fluid Leak

Interventions

BIOLOGICAL

EVICEL Fibrin Sealant

DEVICE

Hydrogel sealant

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Kocharian, MD, PhD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2017-09-13
Completion
2017-10-12

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457546 on ClinicalTrials.gov