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Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)

NCT03225638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2017-07-21

No results posted yet for this study

Summary

The aim of this study is to evaluate the intramuscular nominal thigh injection performance and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit and lower limit). All participants will receive an intramuscular nominal thigh injection, and half of the participants will receive an intramuscular low threshold (upper limit) strength thigh injection, while the other half will receive an intramuscular low threshold (lower limit) strength thigh injection.

Conditions

  • No Condition

Interventions

COMBINATION_PRODUCT

Intramuscular ZENEO® injection of nominal strength

Sodium Chloride (0.9%)

COMBINATION_PRODUCT

Intramuscular ZENEO® injection of low strength (upper limit)

Sodium Chloride (0.9%)

COMBINATION_PRODUCT

Intramuscular ZENEO® injection of low strength (lower limit)

Sodium Chloride (0.9%)

Sponsors & Collaborators

  • Crossject

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2017-09-30
Completion
2017-12-29

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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 NCT03225638 on ClinicalTrials.gov