Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)
NCT ID: NCT03225638
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
86 participants
INTERVENTIONAL
2017-09-01
2017-12-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.
NCT05967013
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
Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers
NCT06261580
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
NCT01834612
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
NCT07120906
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (upper limit) strength thigh injection of 0.65ml of saline solution (0.9%)
Intramuscular ZENEO® injection of nominal strength
Sodium Chloride (0.9%)
Intramuscular ZENEO® injection of low strength (upper limit)
Sodium Chloride (0.9%)
Group 2
Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (lower limit) strength thigh injection of 0.65ml of saline solution (0.9%)
Intramuscular ZENEO® injection of nominal strength
Sodium Chloride (0.9%)
Intramuscular ZENEO® injection of low strength (lower limit)
Sodium Chloride (0.9%)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intramuscular ZENEO® injection of nominal strength
Sodium Chloride (0.9%)
Intramuscular ZENEO® injection of low strength (upper limit)
Sodium Chloride (0.9%)
Intramuscular ZENEO® injection of low strength (lower limit)
Sodium Chloride (0.9%)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Affiliated to or covered by the French social security system
* BMI between ≥ 18 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
* Patient 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.
* Absence of cannabis, opiate, cocaine, amphetamine history
* Written Informed consent
Exclusion Criteria
* 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
* pregnant or breastfeeding woman
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Crossject
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CJT-CS-2017-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.