Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®

Study Overview
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Brief Summary
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Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.

Official Title
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Retrospective, Single Center, Single Arm Post Market Clinical Follow-Up (PMCF) Study on the Performance and Safety of Lyoplant® Used for the Replacement and Extension of Connective Tissue Structures in Neurosurgery

Conditions
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Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain

Intervention / Treatment
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* Device: Lyoplant®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Use of investigational device according to Instructions for Use (IfU) Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lyoplant®<br>Lyoplant® is a pure collagen implant obtained from bovine pericardium. The membrane is used for the replacement and extension of connective tissue structures in neurosurgery. | Device: Lyoplant®<br>* replacement and extension of connective tissue structures in neurosurgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cerebrospinal Fluid Leakage | A Cerebrospinal Fluid (CSF) leakage needs to be confirmed by radiological image evaluation (computed tomography scan, CT or magnetic resonance imaging scan, MRI). It will be documented if the CSF leak was clinically evident or not. A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice (e.g., rhinorrhea or otorrhea) or as subcutaneous visible and / or palpable fluid accumulation next to or at the site of surgical incision suspected to be CSF. A non-clinically evident CSF leak is defined as CSF accumulation which could be detected only by radiological image evaluation (CT / MRI). | at one follow-up ≥ 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of re-operations with product relationship | e.g. caused by infection, foreign-body-reaction/ hypersensitivity against proteins of bovine origin/ allergic reactions to proteins of bovine origin | at one follow-up ≥ 3 months after surgery | 
| Incidence of further (serious) adverse events in chronologic sequence | Number of further serious adverse events e.g. meningitis, surgical site infection, inflammation rate, hematoma - with focus on events with (possible) relation to the investigational product. | intra- and postoperative, until follow-up ≥ 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lyoplant, Retrospective Study, Decompressive Craniectomy, Cerebral Dura Defect, Cerebellar Dura Defect, Spinal Dura Defects