Clinical trial · Observational
MiDura-Study (Neuro-Patch in Duraplasty)
Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)
NCT04189172CI-TRIAL-00105802MiDuraactive not recruitingClinicalTrials.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)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chiari Malformation | — | UNRESOLVED | — |
| Craniotomy | — | UNRESOLVED | — |
| Dural Fistula | — | UNRESOLVED | — |
| Duraplasty | — | UNRESOLVED | — |
| Hydrocephalus | — | UNRESOLVED | — |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Spinal Surgery | — | UNRESOLVED | — |
| Tethered Cord | — | UNRESOLVED | — |
| Tumor, Brain | Brain Neoplasm | ALIAS | 0.90 |
| Vascular Malformation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Neuro-Patch
- description
- Patients receiving Neuro-Patch® for duraplasty
Primary outcomes (1)
- measure
- Incidence of complications
- timeFrame
- until follow-up (up to one year after surgery)
- description
- Incidence of complications, with (potential) causal relationship to Neuro-Patch
Secondary outcomes (2)
- measure
- Handling measures
- timeFrame
- Intraoperative
- description
- Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
- measure
- Incidence of complications not related to Neuro Patch
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age \> 18 years * Duraplasty using Neuro-Patch® according to the Instructions for Use Exclusion Criteria: * Use in infected regions * Use in open cerebrocranial traumata * Use in open spina bifida * Known hypersensitivity to implant materials * Pregnancy * Representation by a legal guardian or under involuntary commitment
References
Publications (0)
Data not yet available
No reference posted for this study.