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NOT YET RECRUITING
NCT07366203
NA

Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Sponsor: NEOS Surgery

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2026-02

Completion Date

2027-12

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DEVICE

SC03 Plating system

Adjustable carbon fiber sternal plates

DEVICE

Stainless steel wires

Nonabsorbable, sterile, surgical sutures used in sternal closure