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CompletedNCT04189172MiDuraUpdated Nov 5, 2026

MiDura-Study (Neuro-Patch in Duraplasty)

An observational study in Meningioma, Tumor, Brain and Chiari Malformation, sponsored by Aesculap AG. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Aesculap AG (part of B. Braun) · Observational

Updated Nov 5, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
328
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

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

Keywords

  • duraplasty
  • dural substitute
  • synthetic graft
  • Neuro-Patch®
03

In context

Meningioma

255 studies on the registry are indexed under Meningioma; 85 are open to participants now.

This study's enrollment of 328 is above the median of 133 across 56 observational studies indexed under Meningioma.

Browse Meningioma studies →

Lead sponsor

Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written
  • Age > 18 years
  • Duraplasty using Neuro-Patch® according to the Instructions for Use

Exclusion criteria

Exclusion Criteria:

  • Use in infected regions
  • Use in open cerebrocranial traumata
  • Use in open spina bifida
  • Known to implant materials
  • Pregnancy
  • Representation by a legal guardian or under involuntary commitment
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
328 participants (actual)

Groups and cohorts

  • Neuro-Patch

    Patients receiving Neuro-Patch® for duraplasty

06

What researchers measure

Primary outcomes

  1. Incidence of complications

    Incidence of complications, with (potential) causal relationship to Neuro-Patch

    Time frame: until follow-up (up to one year after surgery)

Secondary outcomes

  1. Handling measures

    Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)

    Time frame: Intraoperative

  2. Incidence of complications not related to Neuro Patch

    Incidence of complications, without causal relationship to Neuro-Patch

    Time frame: until follow-up (up to one year after surgery)

07

Study locations

4 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Nov 2025, 69 months.

Of 29 observational studies under Meningioma, half reached primary completion within 106 months of starting (the median), counting those still running; a quarter within 60. This study's 69 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: primary completion Jan 2026 → Nov 2025 and completion May 2027 → Nov 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2019
First posted
Dec 6, 2019
StartActual
Feb 6, 2020
Primary completionActual
Nov 26, 2025was Jan 2026
CompletionActual
Nov 26, 2025was May 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 5, 2026
Primary completion
Jan 27, 2026→Nov 26, 2025
Nov 5, 2026
Study completion
May 2027→Nov 26, 2025 (actual)
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Active, not recruiting→Completed
    Primary completion Jan 27, 2026→Nov 26, 2025
    Study completion May 2027→Nov 26, 2025 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04189172
Lead sponsor
Aesculap AG
Responsible party
Sponsor
First posted
Dec 6, 2019
Start date
Feb 6, 2020
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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