MiDura-Study (Neuro-Patch in Duraplasty)

Aesculap

Status: Active, not recruiting

Conditions: Hydrocephalus; Spinal Surgery; Craniotomy; Meningioma; Duraplasty; Dural Fistula; Tethered Cord; Chiari Malformation; Tumor, Brain; Vascular Malformation

Study type: Observational

Funder types: Industry

Identifiers

NCT04189172

AAG-O-H-1630

Details and patient eligibility

About

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

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

328 participants in 1 patient group

Neuro-Patch

Description:

Patients receiving Neuro-Patch® for duraplasty