Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyoplant Onlay | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of re-operation because of Cerebrospinal Fluid leakage | until discharge (approximately 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of re-operation because of Cerebrospinal Fluid leakage | until follow-up (4 ± 2 months) | |
| Incidence of post operative complications | Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult patients
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Darmstadt | Darmstadt | 64283 | Germany | |||
| Klinik für Neurochirurgie |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| until discharge (approximately 1 week, 4±2 months) |
| Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage | detected during routine post operative MRI / CT examinations | until discharge (approximately 1 week, 4±2 months) |
| Intraoperative handling of the device | 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:
| Intraoperative |
| Homburg/Saar |
| 66421 |
| Germany |
| Klinikum Idar-Oberstein | Idar-Oberstein | 55743 | Germany |