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:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05038527
Eligibility Criteria:
Inclusion Criteria:
* Indication for ASD surgery
* Indication for the use of bone graft
* Age ≥ 18 years old at the date of surgery
Exclusion Criteria:
* ASA ≥ 4
* Formally diagnosed with a disease affecting the bone metabolism or wound healing (severe osteoporosis, osteomalacia, Pagets disease, hyperparathyreoidism etc.)
* Disseminated cancer diseases
* Hypersensitivity to any of the i-FACTOR Peptide Enhanced Bone Graft ingredients
* Smoking, extensive alcohol use or abuse of hallucinating drugs
* Severe liver or kidney disorders
* Pregnancy or breastfeeding patients
* Patients estimated not to be able to understand the information sheet or patients, who do not consent to participate in the study.
* Severe psychiatric diseases
* Ongoing infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05038527
Study Brief:
Protocol Section:
NCT05038527