NCT04189172

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2020May 2027

First Submitted

Initial submission to the registry

December 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2026

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

December 4, 2019

Last Update Submit

March 17, 2026

Conditions

Tumor, BrainChiari MalformationVascular MalformationMeningiomaHydrocephalusTethered CordDural FistulaCraniotomySpinal SurgeryDuraplasty

Keywords

duraplastydural substitutesynthetic graftNeuro-Patch®

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications

    Incidence of complications, with (potential) causal relationship to Neuro-Patch

    until follow-up (up to one year after surgery)

Secondary Outcomes (2)

  • Handling measures

    Intraoperative

  • Incidence of complications not related to Neuro Patch

    until follow-up (up to one year after surgery)

Study Arms (1)

Neuro-Patch

Patients receiving Neuro-Patch® for duraplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • Written informed consent
  • Age \> 18 years
  • Duraplasty using Neuro-Patch® according to the Instructions for Use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service de Neurochirurgie, Hôpital de la Cavale Blanche

Brest, 29200, France

Location

Hopital Pierre Wertheimer - HCL

Bron, 69677, France

Location

Klinik für Neurochirurgie, Universitätsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

Krankenhaus Ludmillenstift

Meppen, 49716, Germany

Location

MeSH Terms

Conditions

MeningiomaBrain NeoplasmsArnold-Chiari MalformationVascular MalformationsHydrocephalusSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular AbnormalitiesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 6, 2019

Study Start

February 6, 2020

Primary Completion

January 27, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

FR(2)DE(2)