Assessment of the Performance of LYoplant® ONlay for Duraplasty (LYON)

April 15, 2025 updated by: Aesculap AG

Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt
      • Homburg/Saar, Germany, 66421
        • Klinik für Neurochirurgie
      • Idar-Oberstein, Germany, 55743
        • Klinikum Idar-Oberstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of re-operation because of Cerebrospinal Fluid leakage
Time Frame: until discharge (approximately 1 week)
until discharge (approximately 1 week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of re-operation because of Cerebrospinal Fluid leakage
Time Frame: until follow-up (4 ± 2 months)
until follow-up (4 ± 2 months)
Incidence of post operative complications
Time Frame: until discharge (approximately 1 week, 4±2 months)
Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others
until discharge (approximately 1 week, 4±2 months)
Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage
Time Frame: until discharge (approximately 1 week, 4±2 months)
detected during routine post operative MRI / CT examinations
until discharge (approximately 1 week, 4±2 months)
Intraoperative handling of the device
Time Frame: Intraoperative

Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed:

  • Ease of cutting
  • Needle penetration
  • Adaptation to the tissue
  • Suture retention strength
  • Onlay effect
  • Quality of sealing
  • Thickness
  • Tensile strength
  • Overall satisfaction
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

February 19, 2018

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimated)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-O-H-1403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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