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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT05119595
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age ≥ 18 years
* Use of CranioFix®2 system according to IfU
* Planned postoperative MRI within clinical routine
Exclusion Criteria:
* Pregnancy
* Patients with hypersensitivity to metals or allergies to the implant materials
* Inflammations in the region of the implant site
* Bone conditions that rule out the application of CranioFix®2 titanium clamps
* Use with artificial cranial bone flaps
* Bone tumors in the area supporting the implant
* Degenerative bone diseases
* Missing dura mater
* Application in the facial skull (viscerocranium) and in the orbital or skull-base region
* Combination of implant components from different manufacturers, i.e. additional use of plates and screws on the same bone fragment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05119595
Study Brief:
Protocol Section:
NCT05119595