Clinical trial · Observational
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
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
NCT05441618CI-TRIAL-00084589LYOPLACEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aneurysm Cerebral | — | UNRESOLVED | — |
| Trauma, Brain | — | UNRESOLVED | — |
| Tumor, Cerebellar | Cerebellar Neoplasm | ALIAS | 0.90 |
| Tumor, Cerebral Ventricle | Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lyoplant® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Device: Lyoplant®
Primary outcomes (1)
- measure
- Rate of Cerebrospinal Fluid Leakage
- timeFrame
- at one 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).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Use of investigational device according to Instructions for Use (IfU) Exclusion Criteria: * none
References
Publications (0)
Data not yet available
No reference posted for this study.