Studies
| Study First Submitted Date | 2022-06-28 |
| Study First Posted Date | 2022-07-01 |
| Last Update Posted Date | 2023-08-08 |
| Start Month Year | October 2023 |
| Primary Completion Month Year | April 2024 |
| Verification Month Year | August 2023 |
| Verification Date | 2023-08-31 |
| Last Update Posted Date | 2023-08-08 |
Conditions
| Sequence: | 52194810 | Sequence: | 52194811 | Sequence: | 52194812 | Sequence: | 52194813 |
| Name | Tumor, Cerebral Ventricle | Name | Tumor, Cerebellar | Name | Aneurysm Cerebral | Name | Trauma, Brain |
| Downcase Name | tumor, cerebral ventricle | Downcase Name | tumor, cerebellar | Downcase Name | aneurysm cerebral | Downcase Name | trauma, brain |
Id Information
| Sequence: | 40176400 |
| Id Source | org_study_id |
| Id Value | AAG-O-H-2112 |
Design Groups
| Sequence: | 55620438 |
| Title | Lyoplant® |
| Description | 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. |
Interventions
| Sequence: | 52509598 |
| Intervention Type | Device |
| Name | Lyoplant® |
| Description | replacement and extension of connective tissue structures in neurosurgery |
Keywords
| Sequence: | 79903508 | Sequence: | 79903509 | Sequence: | 79903510 | Sequence: | 79903511 | Sequence: | 79903512 | Sequence: | 79903513 |
| Name | Lyoplant | Name | Retrospective Study | Name | Decompressive Craniectomy | Name | Cerebral Dura Defect | Name | Cerebellar Dura Defect | Name | Spinal Dura Defects |
| Downcase Name | lyoplant | Downcase Name | retrospective study | Downcase Name | decompressive craniectomy | Downcase Name | cerebral dura defect | Downcase Name | cerebellar dura defect | Downcase Name | spinal dura defects |
Design Outcomes
| Sequence: | 177467061 | Sequence: | 177467062 | Sequence: | 177467063 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Rate of Cerebrospinal Fluid Leakage | Measure | Incidence of re-operations with product relationship | Measure | Incidence of further (serious) adverse events in chronologic sequence |
| Time Frame | at one follow-up ≥ 3 months after surgery | Time Frame | at one follow-up ≥ 3 months after surgery | Time Frame | intra- and postoperative, until follow-up ≥ 3 months after surgery |
| Description | 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). | Description | e.g. caused by infection, foreign-body-reaction/ hypersensitivity against proteins of bovine origin/ allergic reactions to proteins of bovine origin | Description | 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. |
Browse Conditions
| Sequence: | 193576744 | Sequence: | 193576741 | Sequence: | 193576742 | Sequence: | 193576743 | Sequence: | 193576745 | Sequence: | 193576746 | Sequence: | 193576747 | Sequence: | 193576748 | Sequence: | 193576749 | Sequence: | 193576750 | Sequence: | 193576751 | Sequence: | 193576752 | Sequence: | 193576753 | Sequence: | 193576758 | Sequence: | 193576759 | Sequence: | 193576760 | Sequence: | 193576754 | Sequence: | 193576755 | Sequence: | 193576756 | Sequence: | 193576757 |
| Mesh Term | Aneurysm | Mesh Term | Cerebral Ventricle Neoplasms | Mesh Term | Cerebellar Neoplasms | Mesh Term | Brain Injuries, Traumatic | Mesh Term | Neoplasms | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Brain Injuries | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System | Mesh Term | Neoplasms by Site | Mesh Term | Infratentorial Neoplasms | Mesh Term | Cerebellar Diseases | Mesh Term | Wounds and Injuries | Mesh Term | Brain Neoplasms | Mesh Term | Central Nervous System Neoplasms | Mesh Term | Nervous System Neoplasms |
| Downcase Mesh Term | aneurysm | Downcase Mesh Term | cerebral ventricle neoplasms | Downcase Mesh Term | cerebellar neoplasms | Downcase Mesh Term | brain injuries, traumatic | Downcase Mesh Term | neoplasms | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | brain injuries | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | infratentorial neoplasms | Downcase Mesh Term | cerebellar diseases | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | brain neoplasms | Downcase Mesh Term | central nervous system neoplasms | Downcase Mesh Term | nervous system neoplasms |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48341313 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Aesculap AG |
Central Contacts
| Sequence: | 12014260 |
| Contact Type | primary |
| Name | Diana Kupferschmid |
| Phone | +49746195 |
| info@aesculap.de | |
| Phone Extension | 0 |
| Role | Contact |
Design Group Interventions
| Sequence: | 68182266 |
| Design Group Id | 55620438 |
| Intervention Id | 52509598 |
Eligibilities
| Sequence: | 30779273 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Population | Patient files from adult patients with indication of surgical diagnosis (e.g. decompressive craniectomy, tumor, aneurysm, trauma etc.) in a single center are revisited and analysed for primary and secondary variables |
| Criteria | Inclusion Criteria: Age ≥ 18 years Use of investigational device according to Instructions for Use (IfU) Exclusion Criteria: none |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253973210 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30525375 |
| Observational Model | Case-Only |
| Time Perspective | Retrospective |
Responsible Parties
| Sequence: | 28891685 |
| Responsible Party Type | Sponsor |