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

NCT05967013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-04-01

No results posted yet for this study

Summary

The aim of this study is to establish with measures of clinical parameters by Magnetic Resonance Imaging (MRI) (e.g. crossing of the muscle fascias, length of run, injection depth, volume injected) performance of 2 configurations of the needle-free injector when used for intramuscular injection on bare skin or through clothing.

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.

Sponsors & Collaborators

  • Crossject

    lead INDUSTRY

Principal Investigators

  • Maxime LUU, MD, PhD · CHU DIJON Bourgogne - Hôpital François Mitterrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2023-10-26
Completion
2024-02-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967013 on ClinicalTrials.gov