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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT06546332
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years,
* Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.
Exclusion Criteria:
* Pregnant or nursing women,
* Patients with intellectual disabilities who cannot follow the instructions of their surgeon,
* Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®,
* Patients with acute or chronic infections, local or systemic,
* Patients with sensitivities or allergies to the implant components (Nickel, Titanium).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06546332
Study Brief:
Protocol Section:
NCT06546332