MiDura-Study (Neuro-Patch in Duraplasty)

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04189172

Studienbeginn:
Februar 2020

Letztes Update:
22.06.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Meningioma, Brain Neoplasms, Hydrocephalus, Arnold-Chiari Malformation, Vascular Malformations, Congenital Abnormalities, Fistula

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Aesculap AG

Collaborator:
-

Kontakt

Greifzu, Dr.
Kontakt:
Phone: +49-7461-95-0
E-Mail: franziska.greifzu@aesculap.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes
66421 Homburg/Saar
(Saarland)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Joachim Oertel, Prof. Dr.» Ansprechpartner anzeigen

Krankenhaus Ludmillenstift
49716 Meppen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Tschan, Dr. med.» Ansprechpartner anzeigen

Studien-Informationen

Brief 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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of complications (Time Frame - until follow-up (up to one year after surgery)):
Incidence of complications, with (potential) causal relationship to Neuro-Patch

Secondary outcome:

1. Handling measures (Time Frame - Intraoperative):
Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)

2. Incidence of complications not related to Neuro Patch (Time Frame - until follow-up (up to one year after surgery)):
Incidence of complications, without causal relationship to Neuro-Patch

Quelle: ClinicalTrials.gov

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