Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 25, 2022

Primary Completion Date

February 1, 2025

Study Completion Date

February 1, 2025

Conditions
HemostaticsHemostasisSpinal DeformitySpinal Fusion
Interventions
DEVICE

Control Group

During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).

DEVICE

ARISTA

"During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site :~* 5g for 5 to 8 instrumented vertebra~* 10g fo 9 or more instrumented vertebra"

Trial Locations (1)

33077

RECRUITING

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

All Listed Sponsors
collaborator

Bard Ltd

INDUSTRY

lead

Polyclinique Bordeaux Nord Aquitaine

OTHER