NCT02678156

Brief Summary

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

February 5, 2016

Last Update Submit

April 15, 2025

Conditions

CraniotomyDuraplastySpinal Surgery

Keywords

Dura mater substituteGraftLyoplantLyostyptLyoplant onlayXenograft

Outcome Measures

Primary Outcomes (1)

  • Incidence of re-operation because of Cerebrospinal Fluid leakage

    until discharge (approximately 1 week)

Secondary Outcomes (4)

  • Incidence of re-operation because of Cerebrospinal Fluid leakage

    until follow-up (4 ± 2 months)

  • Incidence of post operative complications

    until discharge (approximately 1 week, 4±2 months)

  • Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage

    until discharge (approximately 1 week, 4±2 months)

  • Intraoperative handling of the device

    Intraoperative

Study Arms (1)

LYoplant ONlay

Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.

Device: Lyoplant Onlay

Interventions

Lyoplant OnlayDEVICE
LYoplant ONlay

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:

  • Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
  • Written informed consent
  • Life expectancy \> 6 months
  • Age \> 18 years

You may not qualify if:

  • Active local or systemic infections
  • Open cranial trauma
  • Open spina bifida
  • Known hypersensitivity to proteins of bovine origin
  • Representation by a legal guardian or under involuntary commitment
  • Pregnancy
  • Participation in another clinical study
  • Known primary immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Klinik für Neurochirurgie

Homburg/Saar, 66421, Germany

Location

Klinikum Idar-Oberstein

Idar-Oberstein, 55743, Germany

Location

Study Design

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

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2017

Study Completion

February 19, 2018

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)