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

Trauma, Brain Clinical Trial

— LYOPLACE  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05441618
• Other study ID #: AAG-O-H-2112
• Status: Enrolling by invitation
• Start date: April 2, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Cerebral
• Brain Injuries, Traumatic
• Cerebellar Neoplasms
• Trauma, Brain

Intervention

Device:
• Lyoplant®
replacement and extension of connective tissue structures in neurosurgery

Locations

Country	Name	City	State
Germany	Universitätsklinikum Augsburg AöR	Augsburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of re-operations with product relationship	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
Secondary	Incidence of further (serious) adverse events in chronologic sequence	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