Assessment of the Performance of LYoplant® ONlay for Duraplasty

Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02678156

Acronym

LYON

Enrollment

Registered

2016-02-09

Start date

2016-04-30

Completion date

2018-02-19

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy, Duraplasty, Spinal Surgery

Keywords

Dura mater substitute, Graft, Lyoplant, Lyostypt, Lyoplant onlay, Xenograft

Brief 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.

Interventions

DEVICELyoplant Onlay

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of re-operation because of Cerebrospinal Fluid leakage	until discharge (approximately 1 week)

Secondary

Measure	Time frame	Description
Incidence of re-operation because of Cerebrospinal Fluid leakage	until follow-up (4 ± 2 months)	—
Incidence of post operative complications	until discharge (approximately 1 week, 4±2 months)	Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others
Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage	until discharge (approximately 1 week, 4±2 months)	detected during routine post operative MRI / CT examinations
Intraoperative handling of the device	Intraoperative	Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed: * Ease of cutting * Needle penetration * Adaptation to the tissue * Suture retention strength * Onlay effect * Quality of sealing * Thickness * Tensile strength * Overall satisfaction

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026