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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07366203
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 years old.
* Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated.
* Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained.
* Patient able and willing to meet the protocol requirements and to follow postoperative care instructions
Exclusion Criteria:
* Patient with sternal anomalies, such as bone tumours located in the sternum.
* Patient with limited sternum bone blood supply.
* Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel.
* Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum.
* Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery.
* Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain.
* Patient with diagnosis of dementia with a mental status score (MMSE) \< 20.
* Patient with life expectancy lower than 6 months.
* Patient with any other medical process that may compromise or limit the adequate functionality of the implants.
* Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks.
* Patient with signs of latent or active infection or inflammation on the surgical site.
* Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage.
* Patient for whom the closure technique cannot ensure sufficient sternal fixation.
* Parasternal sternotomy.
* Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07366203
Study Brief:
Protocol Section:
NCT07366203