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

June 19, 2023 updated by: Aesculap AG

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Homburg/Saar, Germany, 66421
        • Recruiting
        • Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes
        • Contact:
          • Joachim Oertel, Prof. Dr.
        • Sub-Investigator:
          • Fritz Teping, Dr. med.
      • Meppen, Germany, 49716
        • Recruiting
        • Krankenhaus Ludmillenstift
        • Contact:
          • Tschan, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: until follow-up (up to one year after surgery)
Incidence of complications, with (potential) causal relationship to Neuro-Patch
until follow-up (up to one year after surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handling measures
Time Frame: Intraoperative
Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
Intraoperative
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
until follow-up (up to one year after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1630

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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