MiDura-Study (Neuro-Patch in Duraplasty)

Active, not recruiting

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

• Registration Number: NCT04189172
• Lead Sponsor: Aesculap AG

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Study Start: 2020-02-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 328

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of complications	until follow-up (up to one year after surgery)	Incidence of complications, with (potential) causal relationship to Neuro-Patch

Secondary Outcome Measures

Name	Time	Method
Handling measures	Intraoperative	Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
Incidence of complications not related to Neuro Patch	until follow-up (up to one year after surgery)	Incidence of complications, without causal relationship to Neuro-Patch

Trial Locations

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