Status:
COMPLETED
Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.
Lead Sponsor:
Crossject
Conditions:
Needle-free Injector
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
The aim of this study is to establish with measures of clinical parameters by Magnetic Resonance Imaging (MRI) (e.g. crossing of the muscle fascias, length of run, injection depth, volume injected) pe...
Detailed Description
The development of needle-free injection devices has been motivated by a need for safer and more user-friendly injection devices that can prevent needle-stick injuries and contamination as well as imp...
Eligibility Criteria
Inclusion
- Male or female volunteers aged between 18 and 59 years (inclusive) at the Screening Visit.
- Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile: neither post-menopausal nor surgically sterile) who are sexually active with a non-sterile male partner must be willing to use one of the following effective contraceptive methods throughout the study and for 30 days after the last study intervention:
- Combined estrogen and progestogen-containing or progestogen-only hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the first study intervention;
- Intrauterine device placed at least 4 weeks prior to the first study intervention, and condom for the male partner;
- Simultaneous use of a diaphragm or cervical cap with intravaginally applied spermicide and for the male partner a male condom;
- Sterile male partner (i.e. vasectomized since at least 6 months prior to the first study intervention);
- Sexual abstinence (when in line with the preferred and usual subject lifestyle). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
- Female subjects of non-childbearing potential must be:
- Post-menopausal female (absence of menses for 12 months prior to the first \[if applicable\] study intervention); or
- Surgically sterile female (documented hysterectomy, or bilateral oophorectomy or bilateral tubal ligation/occlusion) or bilateral tubal ligation at least 6 months prior to the first \[if applicable\] study intervention).
- Subject with BMI between ≥ 16.0 and \< 35.0 kg/m² at the Screening Visit.
- Injection sites must be clear of tattoos, scars and moles.
- Affiliated to or covered by the French social security system.
- Signed written consent given for participation in the study.
Exclusion
- Known Contra-Indication to i.m. injection.
- Treatment with platelet inhibiting drugs within one week before inclusion.
- Treatment with anticoagulant within four weeks before inclusion.
- Any Contra-indication to MRI (ex: metallic intra-corporeal devices, claustrophobia, tremor or abnormal movements whatever the origin is).
- A major illness during the 3 months before the screening period, that may interfere with the evaluation, as judged by the investigator
- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator.
- Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
- A pulse \< 45 or \> 90 bpm; mean systolic blood pressure \> 140 mmHg; mean diastolic blood pressure \> 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes.
- Current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females.
- Regular exposure to substances of abuse (other than alcohol) within the past year.
- Positive urine screen for drugs of abuse and for alcohol breath test at screening and before the first study intervention (P1). In case of a positive result, urine screen for drugs may be repeated once at the discretion of the Investigator.
- Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first use of the Investigational Medicinal Device.
- History of hypersensitivity or allergy to any topical disinfectant.
- Positive testing at screening for current infection Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C.
- Breastfeeding woman.
- Positive pregnancy test at screening (β-Human Chorionic Gonadotropin test) and Check-in (Day1-P1) (urine test).
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Participation in another interventional clinical trial within 3 months prior to screening.
- In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.
- Vulnerable subjects, e.g. persons in detention.
- Subject is the Principal Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study or employee of the Sponsor (or representatives).
Key Trial Info
Start Date :
June 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05967013
Start Date
June 12 2023
End Date
February 16 2024
Last Update
April 1 2024
Active Locations (1)
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1
CHU DIJON Bourgogne - Hôpital François Mitterrand
Dijon, France, 21079