NCT03044301

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

January 9, 2017

Last Update Submit

February 2, 2017

Conditions

No Condition

Outcome Measures

Primary Outcomes (1)

  • depth of the injection by MRI

    5 minutes after the injection

Study Arms (4)

BMI < 25kg/m²

OTHER

Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection

Combination Product: Intramuscular ZENEO® injectionCombination Product: Subcutaneous high ZENEO® injection

27.5 > BMI > 25 kg/m²

OTHER

Intramuscular ZENEO® injection

Combination Product: Intramuscular ZENEO® injection

BMI > 27.5 kg/m²

OTHER

Intramuscular ZENEO® injection

Combination Product: Intramuscular ZENEO® injection

No special BMI

OTHER

Subcutaneous low ZENEO® injection

Combination Product: Subcutaneous low ZENEO® injection

Interventions

Intramuscular ZENEO® injectionCOMBINATION_PRODUCT

Sodium Chloride (0.9 %)

27.5 > BMI > 25 kg/m²BMI < 25kg/m²BMI > 27.5 kg/m²
Subcutaneous high ZENEO® injectionCOMBINATION_PRODUCT

Sodium Chloride (0.9 %)

BMI < 25kg/m²
Subcutaneous low ZENEO® injectionCOMBINATION_PRODUCT

Sodium Chloride (0.9 %)

No special BMI

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • Absence of cannabis, opiate, cocaine, amphetamine history (only for MRI sub study volunteers)

You may not qualify if:

  • history of drug abuse
  • history of hypersensitivity (disease or drug)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

February 7, 2017

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 7, 2017

Record last verified: 2017-02