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Clinical Trials/NCT04189172
NCT04189172
Active, Not Recruiting
N/A

Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)

Aesculap AG7 sites in 2 countries328 target enrollmentFebruary 6, 2020
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ConditionsMeningiomaTumor, BrainChiari MalformationVascular MalformationHydrocephalusTethered CordDural FistulaCraniotomySpinal SurgeryDuraplasty

Overview

Phase
N/A
Intervention
Neuro-Patch
Conditions
Meningioma
Sponsor
Aesculap AG
Enrollment
328
Locations
7
Primary Endpoint
Incidence of complications
Status
Active, Not Recruiting
Last Updated
last month
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
February 6, 2020
End Date
May 1, 2027
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Neuro-Patch

Patients receiving Neuro-Patch® for duraplasty

Outcomes

Primary Outcomes

Incidence of complications

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

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

Secondary Outcomes

  • Handling measures(Intraoperative)
  • Incidence of complications not related to Neuro Patch(until follow-up (up to one year after surgery))

Study Sites (7)

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