Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT02678156
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02678156
Study Brief:
Protocol Section:
NCT02678156