Assessment of the Performance of LYoplant® ONlay for Duraplasty

Craniotomy Clinical Trial

— LYON  

Official title:

Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678156
• Other study ID #: AAG-O-H-1403
• Status: Completed
• Start date: April 2016
• Est. completion date: February 19, 2018

Study information

• Verified date: November 2022
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 19, 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
• Written informed consent
• Life expectancy > 6 months
• Age > 18 years

Exclusion Criteria:

• Active local or systemic infections
• Open cranial trauma
• Open spina bifida
• Known hypersensitivity to proteins of bovine origin
• Representation by a legal guardian or under involuntary commitment
• Pregnancy
• Participation in another clinical study
• Known primary immunodeficiency

Related Conditions & MeSH terms

• Craniotomy
• Duraplasty
• Spinal Surgery

Intervention

Device:
• Lyoplant Onlay

Locations

Country	Name	City	State
Germany	Klinikum Darmstadt	Darmstadt
Germany	Klinik für Neurochirurgie	Homburg/Saar
Germany	Klinikum Idar-Oberstein	Idar-Oberstein

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of re-operation because of Cerebrospinal Fluid leakage		until discharge (approximately 1 week)
Secondary	Incidence of re-operation because of Cerebrospinal Fluid leakage		until follow-up (4 ± 2 months)
Secondary	Incidence of post operative complications	Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others	until discharge (approximately 1 week, 4±2 months)
Secondary	Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage	detected during routine post operative MRI / CT examinations	until discharge (approximately 1 week, 4±2 months)
Secondary	Intraoperative handling of the device	Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed: Ease of cutting; Needle penetration; Adaptation to the tissue; Suture retention strength; Onlay effect; Quality of sealing; Thickness; Tensile strength; Overall satisfaction	Intraoperative