MiDura-Study (Neuro-Patch in Duraplasty)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04189172
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aesculap AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation, Hydrocephalus, Tethered Cord, Dural Fistula, Craniotomy, Spinal Surgery, Duraplasty
Arms & Interventions

Arms

: Neuro-Patch

Patients receiving Neuro-Patch® for duraplasty

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Homburg/Saar, Germany

Status

Recruiting

Address

Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes

Homburg/Saar, , 66421

Site Contact

Joachim Oertel, Prof. Dr.

[email protected]

+49-7461-95-0

Krankenhaus Ludmillenstift, Meppen, Germany

Status

Recruiting

Address

Krankenhaus Ludmillenstift

Meppen, , 49716

Site Contact

Tschan, Dr. med.

[email protected]

+49-7461-95-0

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