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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Brain Neoplasms
• Chiari Malformation
• Congenital Abnormalities
• Craniotomy
• Dural Fistula
• Duraplasty
• Fistula
• Hydrocephalus
• Meningioma
• Spinal Surgery
• Tethered Cord
• Tumor, Brain
• Vascular Malformation
• Vascular Malformations

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)