Trials / Withdrawn
WithdrawnNCT05784532
Sternal Fixation With STERN FIX After Medial Sternotomy
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- NEOS Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use. The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system. Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | STERN FIX | Sternotomy closure with STERN FIX and supplemented with wires |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2023-03-27
- Last updated
- 2025-10-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05784532. Inclusion in this directory is not an endorsement.