ENCASE II
ENCASE-II
Randomized, two-arm, multicenter study to evaluate the safety and efficacy of LIQOSEAL® in reducing CSF leakage following elective cranial Surgery.
Primary Objective
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show non-inferiority compared to a control group.
Clinical Trail.gov
Contact
Participating sites
USA | |
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Albuquerque, N | MUNMSC – University New Mexico Science Center |
New York, NY | Lenox Hill Hospital NY |
Dallas, TX | UT Southwestern Medical Center |
Cincinnati, OH | UC Health |
Portland, OR | OHSU – Oregon Health & Science University |
Rochester, AZ | Mayo Clinic |
Phoenix, Az | Mayo Clinic |
Jacksonville, FL | Mayo Clinic |
Stanford, CA | Stanford NHC |
Europe | |
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Utrecht, the Netherlands | UMC Utrecht |
Zürich, Switzerland | UniversitätsSpital Zürich |
Tilburg, the Netherlands | ETZ (Elisabeth-TweeSteden Ziekenhuis) |
Mannheim, Germany | University Hospital Mannheim |
Gent, Belgium | UZ (Universitair Ziekenhuis) Gent |
Innsbruck, Austria | University Hospital of Innsbruck |
Torino, Italy | Città della Salute e della Scienza |
Düsseldorf, Germany | UKD (University Hospital Düsseldorf) |
Start your LIQOSEAL training for the ENCASE II trial
In preparation of the ENCASE II trial, we are happy to introduce you to LIQOSEAL by means of an online product information and training. To start, login with your e-mailaddress and password provided to you by e-mail. The training is accessible 24/7.
Publications
Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol
https://pubmed.ncbi.nlm.nih.gov/31574157/
Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review
https://pubmed.ncbi.nlm.nih.gov/29969744/
Dural sealants for the management of cerebrospinal fluid leakage after intradural surgery: current status and future perspectives
https://pubmed.ncbi.nlm.nih.gov/31144544/
Usefulness of Sealants for Dural Closure: Evaluation in an In Vitro Model
https://pubmed.ncbi.nlm.nih.gov/29281065/
Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases
https://pubmed.ncbi.nlm.nih.gov/16293457/
A Pivotal Randomized Clinical Trial Evaluating the Safety and Effectiveness of a Novel Hydrogel Dural Sealant as an Adjunct to Dural Repair
https://pubmed.ncbi.nlm.nih.gov/28927211/