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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Ultrasound scans

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, 2 to 70 years old, inclusive
2. In stable health, as determined by medical history and physical examination at screening (ie, any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during assessments, so that in the opinion of the investigator or designee there will not be any impact on the ability of the subject to participate in the study)
3. For the adult population, body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m2 at screening BMI = weight (kg)/(height [m])2
4. Willing and able to provide written informed consent and assent (as appropriate) prior to initiation of study procedures
5. Subjects must be able to communicate effectively with the study staff and to understand study instructions (not applicable for toddlers and preschoolers)

Exclusion Criteria:

1. Any skin or muscular condition, such as eczema, scars, infections, moles, or tattoos at the site of measurements
2. Allergy to ultrasound gel
3. Any other condition or prior therapy that, in the investigator or designee's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
4. Is an employee or authorized representative of CROSSJECT SA or ICON plc
5. Adult under guardianship or subject incarcerated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy subjects : Adult and pediatric populations; 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.

Other: Ultrasound scans; Ultrasound scans connected with an application enabling the measurement of the force applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circumferences measurements (thigh, upper arm, waist, hip)	Measurement	Day1

Collaborators and Investigators

• Sponsor: Crossject

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CJTCDZ2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No