MiDura-Study (Neuro-Patch in Duraplasty)

Sponsor

Aesculap AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04189172

Collaborator

(none)

250

Enrollment

Locations

70.8

Anticipated Duration (Months)

125

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Meningioma Tumor, Brain Chiari Malformation Vascular Malformation Hydrocephalus Tethered Cord Dural Fistula Craniotomy Spinal Surgery Duraplasty

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 6, 2020

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Neuro-Patch Patients receiving Neuro-Patch® for duraplasty

Outcome Measures

Primary Outcome Measures

Incidence of complications [until follow-up (up to one year after surgery)]
Incidence of complications, with (potential) causal relationship to Neuro-Patch

Secondary Outcome Measures

Handling measures [Intraoperative]
Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
Incidence of complications not related to Neuro Patch [until follow-up (up to one year after surgery)]
Incidence of complications, without causal relationship to Neuro-Patch