Assessment of the Performance of LYoplant® ONlay for Duraplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Craniotomy Duraplasty Spinal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LYoplant ONlay

Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.

Lyoplant Onlay

Intervention Type DEVICE

Interventions

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Lyoplant Onlay

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No