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®)

Not Applicable

Completed

• Conditions: No Condition
• Interventions: Combination Product: Subcutaneous low ZENEO® injection; Combination Product: Intramuscular ZENEO® injection; Combination Product: Subcutaneous high ZENEO® injection

• Registration Number: NCT03044301
• Lead Sponsor: Crossject

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2017-01-09
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-02
• Last Update Submitted: 2017-02-02
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No special BMI	Subcutaneous low ZENEO® injection	Subcutaneous low ZENEO® injection
BMI < 25kg/m²	Intramuscular ZENEO® injection	Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection
BMI > 27.5 kg/m²	Intramuscular ZENEO® injection	Intramuscular ZENEO® injection
BMI < 25kg/m²	Subcutaneous high ZENEO® injection	Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection
27.5 > BMI > 25 kg/m²	Intramuscular ZENEO® injection	Intramuscular ZENEO® injection

Primary Outcome Measures

Name	Time	Method
depth of the injection by MRI	5 minutes after the injection