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®)

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)

NCT03225638

No Condition

UNKNOWN NA

Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.

NCT05967013

Needle-free Injector

COMPLETED NA

Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw

NCT01834612

Blood Loss

COMPLETED PHASE1

Clinical Evaluation of the Zynex Monitoring System, Model CM-1600

NCT05740644

Fluid Loss

COMPLETED NA

Proof-of-concept Study of LymphMonitor 1.0 to Assess the Lymphatic Vessel Function

NCT04393168

Lymphedema Secondary Lymphedema

COMPLETED PHASE1

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.

No Condition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intramuscular ZENEO® injection

Sodium Chloride (0.9 %)

Intervention Type COMBINATION_PRODUCT

Subcutaneous high ZENEO® injection

Sodium Chloride (0.9 %)

Intervention Type COMBINATION_PRODUCT

Subcutaneous low ZENEO® injection

Sodium Chloride (0.9 %)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes