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

NCT05441618 | Completed

• 1 other identifier: AAG-O-H-2112
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of Cerebrospinal Fluid Leakage

  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 Outcomes (2)

• Incidence of re-operations with product relationship

  at one follow-up ≥ 3 months after surgery

• Incidence of further (serious) adverse events in chronologic sequence

  intra- and postoperative, until follow-up ≥ 3 months after surgery

Study Arms (1)

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®

Interventions

Lyoplant® DEVICE

replacement and extension of connective tissue structures in neurosurgery

Lyoplant®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Universitätsklinikum Augsburg AöR

Augsburg, Bavaria, 86156, Germany

Location

MeSH Terms

Conditions

Cerebral Ventricle Neoplasms; Cerebellar Neoplasms; Intracranial Aneurysm; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Philipp E Krauss, Dr.

  Universitätsklinikum Augsburg AöR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: April 2, 2024
• Primary Completion: December 19, 2024
• Study Completion: January 10, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)