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

NCT ID: NCT05441618

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-02

Study Completion Date

2025-01-10

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Lyoplant®

Intervention Type DEVICE

replacement and extension of connective tissue structures in neurosurgery

Interventions

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Lyoplant®

replacement and extension of connective tissue structures in neurosurgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp E Krauss, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Augsburg AöR

Locations

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Universitätsklinikum Augsburg AöR

Augsburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2112

Identifier Type: -

Identifier Source: org_study_id

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