Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:19 AM
Study NCT ID:
NCT07366203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Sponsor:
NEOS Surgery
Organization:
Study Overview
Official Title:
Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIX IT ALL
Brief Summary:
The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is:
Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery?
Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum).
Participants will:
* be implanted with the SC03 or stainless steel wires.
* visit the clinic one month and six months after surgery
* Keep a diary of their symptoms and analgesia use
Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery?
Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum).
Participants will:
* be implanted with the SC03 or stainless steel wires.
* visit the clinic one month and six months after surgery
* Keep a diary of their symptoms and analgesia use
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: