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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678156
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

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.

Condition or disease Intervention/treatment
Craniotomy Duraplasty Spinal Surgery Device: Lyoplant Onlay

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : February 19, 2018

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



Primary Outcome Measures :
  1. Incidence of re-operation because of Cerebrospinal Fluid leakage [ Time Frame: until discharge (approximately 1 week) ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678156


Locations
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Germany
Klinikum Darmstadt
Darmstadt, Germany, 64283
Klinik für Neurochirurgie
Homburg/Saar, Germany, 66421
Klinikum Idar-Oberstein
Idar-Oberstein, Germany, 55743
Sponsors and Collaborators
Aesculap AG
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT02678156    
Other Study ID Numbers: AAG-O-H-1403
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aesculap AG:
Dura mater substitute
Graft
Lyoplant
Lyostypt
Lyoplant onlay
Xenograft