Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.

NACompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

June 12, 2023

Primary Completion Date

October 26, 2023

Study Completion Date

February 16, 2024

Conditions
Needle-free Injector
Interventions
COMBINATION_PRODUCT

Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing.

"All injections with ZENEO® injector will be performed in the thigh. Due to MRI performance constraints, injection sites will be identified on the same thigh/leg at each treatment period: first leg on treatment period 1, opposite leg on treatment period 2.~At each treatment period, two injection sites will be identified spaced 8 to 15 cm apart. The 2 injections should be performed on the same leg at each treatment period.~In total, 2 injections will be performed per treatment period, and subjects will receive 4 injections during the study :~* 2 injections on bare skin: 1 with GAMMA configuration of ZENEO® injector \& 1 with GAMMA-Low configuration ZENEO® injector.~* 2 injections through clothing: 1 with GAMMA configuration of ZENEO® injector \& 1 with GAMMA-Low configuration ZENEO® injector."

Trial Locations (1)

21079

CHU DIJON Bourgogne - Hôpital François Mitterrand, Dijon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Crossject

INDUSTRY

NCT05967013 - Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®. | Biotech Hunter | Biotech Hunter