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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT06156904
Eligibility Criteria:
Inclusion Criteria:
1. Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
2. Male or female patient ≥ 18 years old.
3. Patients willing and able to attend the standard of care follow-up visits and procedures.
4. Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.
Exclusion Criteria:
1. Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
2. Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
3. Woman who is pregnant or breast-feeding.
4. Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06156904
Study Brief:
Protocol Section:
NCT06156904