EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses

NANot yet recruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
Craniosynostoses
Interventions
DEVICE

BONFIX system

"The device corresponds to a customized, single-use surgical guide (Class IIa medical device), with a set of different sizes, adapted to the fronto-zygomatic distance (FDZ) measurement, in order to enable better conformation of the orbito-naso-frontal bandeau during surgery for anterior craniostenosis, an ideal conformation that could lead to optimal symmetry and adapted to the morphology of the upper third of infants.~The surgeon conforms the orbito-naso-frontal bandeau by adapting the advancement between the device supports according to the FDZ and then positioning it directly on the surgical guide."

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER

NCT06366178 - EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses | Biotech Hunter | Biotech Hunter