Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05441618

Acronym

LYOPLACE

Enrollment

Registered

2022-07-01

Start date

2024-04-02

Completion date

2025-01-10

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Cerebral, Trauma, Brain, Tumor, Cerebellar, Tumor, Cerebral Ventricle

Keywords

Lyoplant, Retrospective Study, Decompressive Craniectomy, Cerebral Dura Defect, Cerebellar Dura Defect, Spinal Dura Defects

Brief 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.

Interventions

DEVICELyoplant®

replacement and extension of connective tissue structures in neurosurgery

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years * Use of investigational device according to Instructions for Use (IfU)

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Rate of Cerebrospinal Fluid Leakage	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).

Secondary

Measure	Time frame	Description
Incidence of re-operations with product relationship	at one follow-up ≥ 3 months after surgery	e.g. caused by infection, foreign-body-reaction/ hypersensitivity against proteins of bovine origin/ allergic reactions to proteins of bovine origin
Incidence of further (serious) adverse events in chronologic sequence	intra- and postoperative, until follow-up ≥ 3 months after surgery	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026