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®)

No Condition Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044301
• Other study ID #: G-E-CJT-XC-150127
• Status: Completed
• Phase: N/A
• First received: January 9, 2017
• Last updated: February 2, 2017
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: Crossject
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• No Condition

Intervention

Combination Product:
• Intramuscular ZENEO® injection
Sodium Chloride (0.9 %)
• Subcutaneous high ZENEO® injection
Sodium Chloride (0.9 %)
• Subcutaneous low ZENEO® injection
Sodium Chloride (0.9 %)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Crossject

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depth of the injection by MRI		5 minutes after the injection