Assessment of the Performance of LYoplant® ONlay for Duraplasty (LYON)

Aesculap

Status: Completed

Conditions: Spinal Surgery; Craniotomy; Duraplasty

Treatments: Device: Lyoplant Onlay

Study type: Observational

Funder types: Industry

Identifiers

NCT02678156

AAG-O-H-1403

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

61 participants in 1 patient group

LYoplant ONlay

Description:

Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.

Treatment:

Device: Lyoplant Onlay