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Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®)

NCT03044301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2017-02-07

No results posted yet for this study

Summary

The aim of this study is to evaluate the performance of the ZENEO needle free device in subcutaneous functioning limits (low performance limit and high performance limit) and for intramuscular injections.

Conditions

  • No Condition

Interventions

COMBINATION_PRODUCT

Intramuscular ZENEO® injection

Sodium Chloride (0.9 %)

COMBINATION_PRODUCT

Subcutaneous high ZENEO® injection

Sodium Chloride (0.9 %)

COMBINATION_PRODUCT

Subcutaneous low ZENEO® injection

Sodium Chloride (0.9 %)

Sponsors & Collaborators

  • Crossject

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

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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 NCT03044301 on ClinicalTrials.gov