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Completed

NCT Number: NCT05441618

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

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.

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Key information

Conditions

Tumor, Cerebral Ventricle Aneurysm Aneurysm Cerebral Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebellar Diseases Cerebellar Neoplasms Cerebral Ventricle Neoplasms Cerebrovascular Disorders Craniocerebral Trauma Infratentorial Neoplasms Intracranial Aneurysm Intracranial Arterial Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Trauma, Brain Trauma, Nervous System Tumor, Cerebellar Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Augsburg AöR

Augsburg, Bavaria, 86156, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Lyoplant®

Device

replacement and extension of connective tissue structures in neurosurgery

Primary outcomes

  1. 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).

Secondary outcomes

  1. Incidence of re-operations with product relationship

    Time frame: 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

  2. Incidence of further (serious) adverse events in chronologic sequence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: LYOPLACE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 1, 2022
Registry last updated
Jan 13, 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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