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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT05784532
Eligibility Criteria:
Inclusion Criteria:
* Older than 18 years old patient
* Patient undergoing surgery requiring medial sternotomy
* Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry
Exclusion Criteria:
* Patients that are still growing.
* Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region.
* Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage.
* Patients with suspected or known allergies or intolerances to the implant material.
* Patients with severe osteoporosis or other degenerative bone diseases.
* Any patient unwilling to, or incapable of, following postoperative care instructions.
* Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant.
* Pregnant patients or planning to become pregnant during the 2 months following surgery.
* Patients with life expectancy lower than 2 months.
* Patients who are or have been participating in an interventionist trial during the last 4 weeks
Intraoperative exclusion criteria
* Latent or active infection, or inflammation in the operating area.
* Signs of infection on the surgical site.
* Parasternal sternotomy.
* When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation.
* When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05784532
Study Brief:
Protocol Section:
NCT05784532