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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT06736457
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects ≥ 18 years old, male or female.
* Subjects who are eligible for a bone grafting/bone void filler procedure.
* Subjects with bone lesions beyond the limits of the bone's self-healing ability.
* Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
* Subjects with only one fracture susceptible to treatment with an AdvanCore implant.
Exclusion Criteria:
* Subjects with any AdvanCore contraindication for implantation or use.
* Subjects with hypersensitivity to any of the AdvanCore components.
* Subjects with infections or soft/granulation tissue in the area to place bone graft.
* Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
* Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06736457
Study Brief:
Protocol Section:
NCT06736457