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OpenTrials
Active, Not Recruiting

NCT Number: NCT04189172

MiDura-Study (Neuro-Patch in Duraplasty)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Meningioma Arnold-Chiari Malformation Brain Diseases Brain Neoplasms Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Chiari Malformation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniotomy Dural Fistula Duraplasty Hydrocephalus Meningeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Neural Tube Defects Spinal Cord Diseases Spinal Cord Injuries Spinal Surgery Tethered Cord Trauma, Nervous System Tumor, Brain Vascular Malformation Vascular Malformations Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Neurochirurgie, Hôpital de la Cavale Blanche, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Handling measures

    Time frame: Intraoperative

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

  2. Incidence of complications not related to Neuro Patch

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

    Incidence of complications, without causal relationship to Neuro-Patch

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: MiDura

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 6, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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