NCT06279689

Echography Study_Anthropometric Measurements

Measurement of Skin-to-Muscle and Skin-to-Bone Distances in Adult and Pediatric Populations Before and While Applying a Force Similar to the ZENEO® Triggering Force

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Crossject · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The exploratory endpoints are as follows: * The skin-to-muscle distance (STMD) (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population * The skin-to-bone distance (STBD) (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population * The thickness of skin layers (mm) (thickness of dermis, thickness of hypodermis \[ie, subcutaneous fat\]) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population * The thickness of muscle layers (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
OTHER	Ultrasound scans	Ultrasound scans connected with an application enabling the measurement of the force applied.

Timeline

• Start date: 2024-02-13
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2024-02-28
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States