Tumor, Cerebral VentricleLYOPLACENCT05441618
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
An observational study of Tumor, Cerebral Ventricle and Tumor, Cerebellar, run by Aesculap AG at 1 site in Germany.
Trial summary
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral
- What is being tested?
- Lyoplant®
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 2 Apr 2024to 10 Jan 2025
- 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: Patient files from adult patients with indication of surgical diagnosis (e.g. decompressive craniectomy, tumor, aneurysm, trauma etc.) in a single center are revisited and analysed for primary and secondary variables
Who may be able to join
- Age ≥ 18 years
- Use of investigational device according to Instructions for Use (IfU)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective, Single Center, Single Arm Post Market Clinical Follow-Up (PMCF) Study on the Performance and Safety of Lyoplant® Used for the Replacement and Extension of Connective Tissue Structures in Neurosurgery
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Being tested
- Lyoplant®
- Keywords
- Lyoplant, Retrospective Study, Decompressive Craniectomy, Cerebral Dura Defect, Cerebellar Dura Defect, Spinal Dura Defects
- Medical subject headings
- Cerebral Ventricle Neoplasms, Cerebellar Neoplasms, Intracranial Aneurysm, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyoplant®Device
replacement and extension of connective tissue structures in neurosurgery
| Study group | Role | What they receive |
|---|---|---|
| Lyoplant® | Lyoplant® is a pure collagen implant obtained from bovine pericardium. The membrane is used for the replacement and extension of connective tissue structures in neurosurgery. Receives: Device: Lyoplant® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cerebrospinal Fluid Leakage
A Cerebrospinal Fluid (CSF) leakage needs to be confirmed by radiological image evaluation (computed tomography scan, CT or magnetic resonance imaging scan, MRI). It will be documented if the CSF leak was clinically evident or not. A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice (e.g., rhinorrhea or otorrhea) or as subcutaneous visible and / or palpable fluid accumulation next to or at the site of surgical incision suspected to be CSF. A non-clinically evident CSF leak is defined as CSF accumulation which could be detected only by radiological image evaluation (CT / MRI).
Measured: at one follow-up ≥ 3 months after surgery
Secondary outcomes (2)
Incidence of re-operations with product relationship
e.g. caused by infection, foreign-body-reaction/ hypersensitivity against proteins of bovine origin/ allergic reactions to proteins of bovine origin
Measured: at one follow-up ≥ 3 months after surgery
Incidence of further (serious) adverse events in chronologic sequence
Number of further serious adverse events e.g. meningitis, surgical site infection, inflammation rate, hematoma - with focus on events with (possible) relation to the investigational product.
Measured: intra- and postoperative, until follow-up ≥ 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start2 Apr 2024
- Primary completion19 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, Cerebral VentricleStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp E Krauss, Dr., Principal investigator, Universitätsklinikum Augsburg AöR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441618
- Sponsor's protocol ID
- AAG-O-H-2112
- Acronym
- LYOPLACE
- Status last verified
- Jan 2025
- First submitted
- 28 Jun 2022
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Single Center, Single Arm Post Market Clinical Follow-Up (PMCF) Study on the Performance and Safety of Lyoplant® Used for the Replacement and Extension of Connective Tissue Structures in Neurosurgery
- ClinicalTrials.gov ID
- NCT05441618
- Acronym / sponsor ID
- LYOPLACE / AAG-O-H-2112
- Keywords
- Lyoplant, Retrospective Study, Decompressive Craniectomy, Cerebral Dura Defect, Cerebellar Dura Defect, Spinal Dura Defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 1 Jul 2022 (actual)
- 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.
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lyoplant® | – | Device: Lyoplant®Lyoplant® is a pure collagen implant obtained from bovine pericardium. The membrane is used for the replacement and extension of connective tissue structures in neurosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient files from adult patients with indication of surgical diagnosis (e.g. decompressive craniectomy, tumor, aneurysm, trauma etc.) in a single center are revisited and analysed for primary and secondary variables
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Use of investigational device according to Instructions for Use (IfU)
Key exclusion criteria (1 listed)
- none
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®replacement and extension of connective tissue structures in neurosurgery | Device | Lyoplant® |
Primary outcome
Rate of Cerebrospinal Fluid Leakage
Time frame: at one follow-up ≥ 3 months after surgery
A Cerebrospinal Fluid (CSF) leakage needs to be confirmed by radiological image evaluation (computed tomography scan, CT or magnetic resonance imaging scan, MRI). It will be documented if the CSF leak was clinically evident or not. A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice (e.g., rhinorrhea or otorrhea) or as subcutaneous visible and / or palpable fluid accumulation next to or at the site of surgical incision suspected to be CSF. A non-clinically evident CSF leak is defined as CSF accumulation which could be detected only by radiological image evaluation (CT / MRI).
2 secondary outcomes
Incidence of re-operations with product relationship
Time frame: at one follow-up ≥ 3 months after surgery
Incidence of further (serious) adverse events in chronologic sequence
Time frame: intra- and postoperative, until follow-up ≥ 3 months after surgery
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 13 Jan 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.
Philipp E Krauss, Dr. principal investigator
Universitätsklinikum Augsburg AöR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor, Cerebral Ventricle and Tumor, Cerebellar, run by Aesculap AG at 1 site 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 2 inclusion and 1 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of Cerebrospinal Fluid Leakage (time frame: at one follow-up ≥ 3 months after surgery). 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 13 Jan 2025.