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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02457546
Study type Interventional
Source Ethicon, Inc.
Contact
Status Completed
Phase Phase 3
Start date July 1, 2015
Completion date October 12, 2017

See also
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Withdrawn NCT02902133 - Acetazolamide to Prevent Post Operative CSF Leak Phase 2
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Completed NCT03566602 - Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery N/A
Completed NCT02891070 - Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery Phase 3
Recruiting NCT04490629 - The Efficacy and Safety of a Latest Dural Substitute N/A
Withdrawn NCT04351061 - Acetazolamide for the Prevention of Post Operative CSF Leak Phase 2
Recruiting NCT04086550 - Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery N/A
Completed NCT04145544 - A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair. N/A
Completed NCT04124523 - Perioperative CSF Leak Management - an Opinion Study
Active, not recruiting NCT04923867 - Suturable DuraGen™ PMCF Study
Withdrawn NCT03181464 - Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics Phase 4