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OpenTrials
Completed

NCT Number: NCT02678156

Assessment of the Performance of LYoplant® ONlay for Duraplasty

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.

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Key information

Conditions

Craniotomy Duraplasty Spinal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Darmstadt, Darmstadt, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lyoplant Onlay

Device

Primary outcomes

  1. Incidence of re-operation because of Cerebrospinal Fluid leakage

    Time frame: until discharge (approximately 1 week)

Secondary outcomes

  1. Incidence of re-operation because of Cerebrospinal Fluid leakage

    Time frame: until follow-up (4 ± 2 months)

  2. Incidence of post operative complications

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

    Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: LYON

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 9, 2016
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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