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MiDura-Study (Neuro-Patch in Duraplasty)

NCT ID: NCT04189172

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-06

Study Completion Date

2027-05-31

Brief Summary

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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

Detailed Description

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Conditions

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

Keywords

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duraplasty dural substitute synthetic graft Neuro-Patch®

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neuro-Patch

Patients receiving Neuro-Patch® for duraplasty

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Neurochirurgie, Hôpital de la Cavale Blanche

Brest, , France

Site Status

Hopital Pierre Wertheimer - HCL

Bron, , France

Site Status

Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Site Status

Krankenhaus Ludmillenstift

Meppen, , Germany

Site Status

Countries

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France Germany

Other Identifiers

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AAG-O-H-1630

Identifier Type: -

Identifier Source: org_study_id