NCT07366203

Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: NEOS Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sternotomy Closure,Open Heart Surgery

Interventions

Type	Name	Description
DEVICE	SC03 Plating system	Adjustable carbon fiber sternal plates
DEVICE	Stainless steel wires	Nonabsorbable, sterile, surgical sutures used in sternal closure

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2026-01-26
• Last updated: 2026-01-26