MiDura-Study (Neuro-Patch in Duraplasty) | NCT04189172

Studies
MiDura-Study (Neuro-Patch in Duraplasty)

NCT04189172

Sponsor

Aesculap AG

Status

Active, not recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

328Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2020Actual

Primary Completion Date

Jan 27, 2026Actual

Completion Date

May 2027Estimated

First Submitted Date

Dec 4, 2019

First Submission Date that Met QC Criteria

Dec 4, 2019

First Posted Date

Dec 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

328Actual

Label	Type	Description	Intervention Names
Neuro-Patch		Patients receiving Neuro-Patch® for duraplasty

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Handling measures	Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)	Intraoperative
Incidence of complications not related to Neuro Patch

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Neurochirurgie, Hôpital de la Cavale Blanche		Brest		29200	France
Hopital Pierre Wertheimer - HCL

Condition Browse Module

MeSH Terms

ID	Term
D008579	Meningioma
D001932	Brain Neoplasms
D001139	Arnold-Chiari Malformation
D054079	Vascular Malformations
D006849	Hydrocephalus
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D009380	Neoplasms, Nerve Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009383	Neoplasms, Vascular Tissue

Browse Leaves

Not provided

Browse Branches

Not provided