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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®)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03044301
Enrollment
97
Registered
2017-02-07
Start date
2015-03-31
Completion date
2016-06-30
Last updated
2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No Condition

Brief 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.

Interventions

COMBINATION_PRODUCTIntramuscular ZENEO® injection

Sodium Chloride (0.9 %)

COMBINATION_PRODUCTSubcutaneous high ZENEO® injection

Sodium Chloride (0.9 %)

COMBINATION_PRODUCTSubcutaneous low ZENEO® injection

Sodium Chloride (0.9 %)

Sponsors

Crossject
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* male or female healthy volunteers aged between 18 and 60 years, * affiliated to or covered by the French social security system, * BMI between ≥20 and ≤30 kg/m² * Patients without chronic medical or surgical illness * Patients with normal clinical examination at the screening visit, * Patients with normal blood pressure at the screening visit: systolic BP \< 140 mmHg and diastolic BP \< 90 mmHg, determined with the patient seated and resting for at least 5 minutes, * Patients within normal range values for the following laboratory tests (appendix I) unless the investigator considers an abnormality to be clinically irrelevant (to be documented and agreed with the sponsor before inclusion) within 1 month prior to the start of the study (only for MRI sub study volunteers), * Absence of cannabis, opiate, cocaine, amphetamine history (only for MRI sub study volunteers)

Exclusion criteria

* history of drug abuse * history of hypersensitivity (disease or drug) * treatment with platelet inhibiting drugs within one week before inclusion * treatment with anticoagulant within four weeks before inclusion * subject likely to take any medication during the study * contra-indication to MRI: metallic intra-corporeal devices, claustrophobia * prior participation to other interventional clinical research within 3 months * in custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.

Design outcomes

Primary

MeasureTime frame
depth of the injection by MRI5 minutes after the injection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026