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

January 10, 2025 updated by: Aesculap AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Augsburg, Bayern, Germany, 86156
        • Universitätsklinikum Augsburg AöR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Lyoplant®
replacement and extension of connective tissue structures in neurosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at one follow-up ≥ 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
intra- and postoperative, until follow-up ≥ 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Philipp E Krauss, Dr., Universitätsklinikum Augsburg AöR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Actual)

December 19, 2024

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-2112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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