CraniotomyLYONNCT02678156
Assessment of the Performance of LYoplant® ONlay for Duraplasty
An observational study of Craniotomy and Duraplasty, run by Aesculap AG at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy, Duraplasty, Spinal Surgery
- What is being tested?
- Lyoplant Onlay
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2016to 19 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum Darmstadt
Darmstadt, 64283
Klinik für Neurochirurgie
Homburg/Saar, 66421
Klinikum Idar-Oberstein
Idar-Oberstein, 55743
About this study
Official title: 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.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Being tested
- Lyoplant Onlay
- Keywords
- Dura mater substitute, Graft, Lyoplant, Lyostypt, Lyoplant onlay, Xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyoplant OnlayDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lyoplant Onlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of re-operation because of Cerebrospinal Fluid leakage
Measured: until discharge (approximately 1 week)
Secondary outcomes (4)
Incidence of re-operation because of Cerebrospinal Fluid leakage
Measured: until follow-up (4 ± 2 months)
Incidence of post operative complications
Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others
Measured: until discharge (approximately 1 week, 4±2 months)
Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage
detected during routine post operative MRI / CT examinations
Measured: until discharge (approximately 1 week, 4±2 months)
Intraoperative handling of the device
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
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678156
- Sponsor's protocol ID
- AAG-O-H-1403
- Acronym
- LYON
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2016
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.
- ClinicalTrials.gov ID
- NCT02678156
- Acronym / sponsor ID
- LYON / AAG-O-H-1403
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Keywords
- Dura mater substitute, Graft, Lyoplant, Lyostypt, Lyoplant onlay, Xenograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LYoplant ONlay | – | Device: Lyoplant OnlayPrimary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyoplant Onlay | Device | LYoplant ONlay |
Primary outcome
Incidence of re-operation because of Cerebrospinal Fluid leakage
Time frame: until discharge (approximately 1 week)
4 secondary outcomes
Incidence of re-operation because of Cerebrospinal Fluid leakage
Time frame: until follow-up (4 ± 2 months)
Incidence of post operative complications
Time frame: 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)
Intraoperative handling of the device
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy and Duraplasty, run by Aesculap AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of re-operation because of Cerebrospinal Fluid leakage (time frame: until discharge (approximately 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.