No ConditionNCT03044301
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®)
A study testing Intramuscular ZENEO® injection, Subcutaneous high ZENEO® injection and Subcutaneous low ZENEO® injection in people with No Condition, run by Crossject.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition
- What is being tested?
- Intramuscular ZENEO® injection, Subcutaneous high ZENEO® injection and Subcutaneous low ZENEO® injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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.
- Conditions
- No Condition
- Being tested
- Intramuscular ZENEO® injection, Subcutaneous high ZENEO® injection, Subcutaneous low ZENEO® injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular ZENEO® injectionCombination product
Sodium Chloride (0.9 %)
Subcutaneous high ZENEO® injectionCombination product
Sodium Chloride (0.9 %)
Subcutaneous low ZENEO® injectionCombination product
Sodium Chloride (0.9 %)
| Study group | Role | What they receive |
|---|---|---|
| BMI < 25kg/m² | Other | Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection Receives: Combination Product: Intramuscular ZENEO® injection; Combination Product: Subcutaneous high ZENEO® injection |
| 27.5 > BMI > 25 kg/m² | Other | Intramuscular ZENEO® injection Receives: Combination Product: Intramuscular ZENEO® injection |
| BMI > 27.5 kg/m² | Other | Intramuscular ZENEO® injection Receives: Combination Product: Intramuscular ZENEO® injection |
| No special BMI | Other | Subcutaneous low ZENEO® injection Receives: Combination Product: Subcutaneous low ZENEO® injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of the injection by MRI
Measured: 5 minutes after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crossject
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044301
- Sponsor's protocol ID
- G-E-CJT-XC-150127
- Status last verified
- Feb 2017
- First submitted
- 9 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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®)
- ClinicalTrials.gov ID
- NCT03044301
- Acronym / sponsor ID
- G-E-CJT-XC-150127
- Conditions
- No Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- CrossjectIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMI < 25kg/m² | Other | Combination Product: Intramuscular ZENEO® injection, Combination Product: Subcutaneous high ZENEO® injectionSubcutaneous high ZENEO® injection Intramuscular ZENEO® injection |
| 27.5 > BMI > 25 kg/m² | Other | Combination Product: Intramuscular ZENEO® injectionIntramuscular ZENEO® injection |
| BMI > 27.5 kg/m² | Other | Combination Product: Intramuscular ZENEO® injectionIntramuscular ZENEO® injection |
| No special BMI | Other | Combination Product: Subcutaneous low ZENEO® injectionSubcutaneous low ZENEO® injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular ZENEO® injectionSodium Chloride (0.9 %) | Combination product | 27.5 > BMI > 25 kg/m², BMI < 25kg/m², BMI > 27.5 kg/m² |
| Subcutaneous high ZENEO® injectionSodium Chloride (0.9 %) | Combination product | BMI < 25kg/m² |
| Subcutaneous low ZENEO® injectionSodium Chloride (0.9 %) | Combination product | No special BMI |
Primary outcome
depth of the injection by MRI
Time frame: 5 minutes after the injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular ZENEO® injection, Subcutaneous high ZENEO® injection and Subcutaneous low ZENEO® injection in people with No Condition, run by Crossject.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depth of the injection by MRI (time frame: 5 minutes after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.