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®)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Crossject
- Enrollment
- 97
- Primary Endpoint
- depth of the injection by MRI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
BMI < 25kg/m²
Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection
Intervention: Intramuscular ZENEO® injection (Combination Product)
BMI < 25kg/m²
Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection
Intervention: Subcutaneous high ZENEO® injection (Combination Product)
27.5 > BMI > 25 kg/m²
Intramuscular ZENEO® injection
Intervention: Intramuscular ZENEO® injection (Combination Product)
BMI > 27.5 kg/m²
Intramuscular ZENEO® injection
Intervention: Intramuscular ZENEO® injection (Combination Product)
No special BMI
Subcutaneous low ZENEO® injection
Intervention: Subcutaneous low ZENEO® injection (Combination Product)
Outcomes
Primary Outcomes
depth of the injection by MRI
Time Frame: 5 minutes after the injection
Secondary Outcomes
No secondary outcomes reported