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

Completed

• Conditions: Trauma, Brain; Tumor, Cerebral Ventricle; Aneurysm Cerebral; Tumor, Cerebellar
• Interventions: Device: Lyoplant®

• Registration Number: NCT05441618
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Study Start: 2024-04-02
• Primary Completion: 2024-12-19
• Status Verified: 2025-01
• Study Completion: 2025-01-10
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lyoplant®	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universitätsklinikum Augsburg AöR; 🇩🇪 Augsburg, Bayern, Germany