MiDura-Study (Neuro-Patch in Duraplasty)

N/AActive Not RecruitingNCT04189172

Aesculap AG328 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

328

Conditions

Meningioma Tumor, Brain Chiari Malformation Vascular Malformation Hydrocephalus Tethered Cord Dural Fistula Craniotomy Spinal Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Incidence of complications

Incidence of complications, with (potential) causal relationship to Neuro-Patch

Time frame: until follow-up (up to one year after surgery)

Secondary Outcomes

Handling measures

Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)

Time frame: Intraoperative

Incidence of complications not related to Neuro Patch

Incidence of complications, without causal relationship to Neuro-Patch

Time frame: until follow-up (up to one year after surgery)

Data from ClinicalTrials.gov

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