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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189172
Recruitment Status : Not yet recruiting
First Posted : December 6, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

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

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

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026


Group/Cohort
Neuro-Patch
Patients receiving Neuro-Patch® for duraplasty



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189172


Contacts
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Contact: Greifzu, Dr. +49-7461-95-0 franziska.greifzu@aesculap.de

Locations
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Germany
Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Sponsors and Collaborators
Aesculap AG

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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT04189172    
Other Study ID Numbers: AAG-O-H-1630
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Keywords provided by Aesculap AG:
duraplasty
dural substitute
synthetic graft
Neuro-Patch®
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Meningioma
Hydrocephalus
Arnold-Chiari Malformation
Vascular Malformations
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical
Nervous System Diseases
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Neural Tube Defects
Nervous System Malformations