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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03709693
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years of age, no upper limit
2. Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement along with other cardiac surgical procedures\] and closed with the SternaLock Blu Sternal Closure System
3. Willing and able to return for follow-up
Exclusion Criteria:
Preoperative
4. Emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
5. Any contraindication listed in the SternaLock Blu instructions for use (IFU/ Appendix 3) (active infection, foreign body sensitivity, or mental/ neurologic conditions who are unwilling or incapable of following post-operative care instructions) Operative
6. Delayed sternal closure required for any reason
7. Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation, i.e.: insufficient quantity of sternal bone or compressible sternum indicating poor bone quality, as assessed by the operating surgeon using his or her professional judgment at the time of closure
8. Use of bone wax between the sternal halves
9. Intraoperative death prior to device placement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03709693
Study Brief:
Protocol Section:
NCT03709693