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NCT04189172 Clinical Trial

MiDura-Study (Neuro-Patch in Duraplasty)

Hydrocephalus Clinical Trial

— MiDura  

Official title:
Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04189172
Other study ID # AAG-O-H-1630
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2020
Est. completion date January 2026

Study information
Verified date May 2024
Source Aesculap AG
Contact Izabela Firkowska Boden, Dr.
Phone +49-7461-95-0
Email info@aesculap.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes Homburg/Saar
Germany Krankenhaus Ludmillenstift Meppen

Sponsors (1)
Lead Sponsor Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of complications Incidence of complications, with (potential) causal relationship to Neuro-Patch until follow-up (up to one year after surgery)
Secondary Handling measures Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor) Intraoperative
Secondary Incidence of complications not related to Neuro Patch Incidence of complications, without causal relationship to Neuro-Patch until follow-up (up to one year after surgery)
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