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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT05953259
Eligibility Criteria:
Inclusion Criteria:
* Patient undergoing surgery that requires median sternotomy
* Patients with at least one of the following risk criteria: obesity (BMI\>30), diabetes, COPD, non serious osteoporosis (not associated with fractures), creatinine \> 200 µmol/L and/or under dialysis treatment, scheduled Bilateral Internal Mammary Artery (BIMA) grafting
* Patients willing and capable of granting informed consent to participate in clinical research and who have granted written consent
* Patient willing and capable of complying with the protocol requirements
Exclusion Criteria:
* Patient with suspected or known allergies or intolerance to the device material (PEEK - polyether-ether-ketone and carbon fibre)
* Patient with insufficient quality or quantity of bone or any other serious structural bone damage at the sternum
* Patient with serious osteoporosis (associated with fractures) or a degenerative bone disease affecting the sternum
* Patients with a latent or active infection or inflammation at the surgical area, that according to the surgeon criteria may interfere in the device implantation or proper function.
* Patient with sternal anomalies that, according to the surgeon criteria, prevent the use of the product, such as bone tumours in the implantation area.
* Pregnant patients or patients planning to become pregnant during the first 6 months after surgery.
* Patients with diagnosis of dementia with a mental status score (MMSE) \< 20.
* Patients with life expectancy lower than 6 months.
* Patients involved in other interventionist clinical trials or that have been involved in other interventionist clinical trials during the previous 4 weeks
* Parasternal sternotomy.
* Patients with intraoperative conditions that, according to the surgeon's opinion, require or exclude the use of a specific sternal closure system, or that cannot be closed following the study products instructions for use.
IMPORTANT: When the allocated closure method is wires only, the surgeon must assess whether the patient could have also had STERN FIX implanted in order to decide if the patient can continue in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05953259
Study Brief:
Protocol Section:
NCT05953259