Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.
In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.
Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed.
The exploratory endpoints are as follows:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects : Adult and pediatric populations | Experimental | Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed is to evaluate the anatomical characteristics of both anterolateral thighs, one shoulder (deltoid) and one upper arm (biceps and triceps) before and while applying a force similar to the ZENEO® triggering force. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound scans | Other | Ultrasound scans connected with an application enabling the measurement of the force applied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| STBD : Skin To Bone Distance | Distance measurement | Day1 |
| STMD: Skin To Muscle Distance | Distance measurement | Day1 |
| Thickness of skin layers (dermis, hypodermis) | Thickness measurement | Day1 |
| Thickness of muscle layers | Thickness measurement | Day1 |
| Measure | Description | Time Frame |
|---|---|---|
| Circumferences measurements (thigh, upper arm, waist, hip) | Measurement | Day1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier LACOMBE | Contact | +33617685235 | o.lacombe@crossject.com | |
| Nathalie Loughraieb | Contact | +33380549850 | n.loughraieb@crossject.com |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie LOUGHRAIEB | Crossject | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials of Texas, LLC dba Flourish Research | Recruiting | San Antonio | Texas | 78229 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided