MiDura-Study (Neuro-Patch in Duraplasty)

NCT04189172 · tracked via the Priya Life Science Germany tracker

Sponsor

Aesculap AG

Phase

Observational

Started

2020-02-06

Last updated

2026-03-18

Condition(s) studied

MeningiomaTumor, BrainChiari MalformationVascular MalformationHydrocephalusTethered CordDural FistulaCraniotomySpinal SurgeryDuraplasty

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of complications — until follow-up (up to one year after surgery)
Incidence of complications, with (potential) causal relationship to Neuro-Patch

Trial sites (4)

Facility	City	Region
Service de Neurochirurgie, Hôpital de la Cavale Blanche	Brest	France
Hopital Pierre Wertheimer - HCL	Bron	France
Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes	Homburg/Saar	Germany
Krankenhaus Ludmillenstift	Meppen	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04189172 on ClinicalTrials.gov ↗ ← All trials in Germany