MeningiomaMiDuraNCT04189172
MiDura-Study (Neuro-Patch in Duraplasty)
An observational study of Meningioma and Tumor, Brain, run by Aesculap AG at 4 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma, Tumor, Brain, Chiari Malformation
- How many people
- 328 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Feb 2020to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Written informed consent
- Age > 18 years
- Duraplasty using Neuro-Patch® according to the Instructions for Use
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France2 sites
Service de Neurochirurgie, Hôpital de la Cavale Blanche
Brest, 29200
Hopital Pierre Wertheimer - HCL
Bron, 69677
Germany2 sites
Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Krankenhaus Ludmillenstift
Meppen, 49716
About this study
Official title: Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)
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
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation, Hydrocephalus, Tethered Cord
- Keywords
- duraplasty, dural substitute, synthetic graft, Neuro-Patch®
- Medical subject headings
- Meningioma, Brain Neoplasms, Arnold-Chiari Malformation, Vascular Malformations, Hydrocephalus, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Patch | Patients receiving Neuro-Patch® for duraplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Incidence of complications, with (potential) causal relationship to Neuro-Patch
Measured: until follow-up (up to one year after surgery)
Secondary outcomes (2)
Handling measures
Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
Measured: Intraoperative
Incidence of complications not related to Neuro Patch
Incidence of complications, without causal relationship to Neuro-Patch
Measured: until follow-up (up to one year after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start6 Feb 2020
- Primary completion27 Jan 2026
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189172
- Sponsor's protocol ID
- AAG-O-H-1630
- Acronym
- MiDura
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)
- ClinicalTrials.gov ID
- NCT04189172
- Acronym / sponsor ID
- MiDura / AAG-O-H-1630
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation, Hydrocephalus, Tethered Cord
- Keywords
- duraplasty, dural substitute, synthetic graft, Neuro-Patch®
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro-Patch | – | –Patients receiving Neuro-Patch® for duraplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- Written informed consent
- Age > 18 years
- Duraplasty using Neuro-Patch® according to the Instructions for Use
Key exclusion criteria (6 listed)
- Use in infected regions
- Use in open cerebrocranial traumata
- Use in open spina bifida
- Known hypersensitivity to implant materials
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of complications
Time frame: until follow-up (up to one year after surgery)
Incidence of complications, with (potential) causal relationship to Neuro-Patch
2 secondary outcomes
Handling measures
Time frame: Intraoperative
Incidence of complications not related to Neuro Patch
Time frame: until follow-up (up to one year after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma and Tumor, Brain, run by Aesculap AG at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: until follow-up (up to one year after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.