CompletedNot Applicable

Assessment of the Performance of LYoplant® ONlay for Duraplasty

Germany61 participantsStarted 2016-04

Plain-language summary

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay * Written informed consent * Life expectancy \> 6 months * Age \> 18 years Exclusion Criteria: * Active local or systemic infections * Open cranial trauma * Open spina bifida * Known hypersensitivity to proteins of bovine origin * Representation by a legal guardian or under involuntary commitment * Pregnancy * Participation in another clinical study * Known primary immunodeficiency

What they're measuring

Incidence of re-operation because of Cerebrospinal Fluid leakage

Timeframe: until discharge (approximately 1 week)

Trial details

NCT IDNCT02678156

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-10

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