NCT05953259View on ClinicalTrials.gov

RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

NAActive, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 27, 2023

Primary Completion Date

June 26, 2025

Study Completion Date

December 31, 2025

Conditions
Median Sternotomy
Interventions
DEVICE

Combination of STERN FIX and wires

Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.

DEVICE

Wires

Closure of the median sternotomy using the standard of care with steel wires.

Trial Locations (5)

28041

Hospital Universitario 12 de Octubre, Madrid

31008

Complejo Hospitalario de Navarra, Pamplona

41013

Hospital Universitario Virgen del Rocio, Seville

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

08036

Hospital Clínic de Barcelona, Barcelona

All Listed Sponsors
collaborator

Hospital Clinic of Barcelona

OTHER

collaborator

Complejo Hospitalario de Navarra

OTHER

collaborator

Universitätsklinikum Freiburg

UNKNOWN

lead

NEOS Surgery

INDUSTRY

NCT05953259 - RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy | Biotech Hunter | Biotech Hunter