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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04593732
Eligibility Criteria:
Inclusion Criteria:
* Patient over 18 years old.
* Patient who must have surgery in which a medium sternotomy is indicated.
* Subjects able to give their voluntary informed consent to participate in clinical research and from which written consent has been obtained.
* The subject is able to meet the requirements of the protocol and is willing to do so.
Exclusion Criteria:
* Patient with suspicious or known allergies or intolerance to implant material (PEEK - polyetheretherketone).
* Patient with limitations in blood supply, insufficient bone quantity or quality, severe osteoporosis, osteomalacia or other serious bone structural damage, which, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
* Degenerative bone diseases.
* Patients with a latent or active infection or inflammation in the operating area that, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
* Patients with fever or leukocytosis.
* Patient with spinal abnormalities that, according to the surgeon's discretion, prevent the use of the product, such as bone tumors located in the implant region.
* Patients who are pregnant or interested in becoming pregnant within 6 months of surgery.
* Nursing patients.
* Patients with life expectancy less than 6 months.
* Patients who are participating in or participating in the previous 4 weeks in another interventional clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04593732
Study Brief:
Protocol Section:
NCT04593732