Echography Study_Anthropometric Measurements

Status unconfirmed · Not applicable

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT06279689

Run by

Crossject

People needed

90

Starts

2024-02-13

Expected to finish

2024-09-01

Last updated by the study team

2024-07-22

Who can join

Age: 2 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, 2 to 70 years old, inclusive
• 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)
• For the adult population, body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m2 at screening BMI = weight (kg)/(height [m])2
• Willing and able to provide written informed consent and assent (as appropriate) prior to initiation of study procedures
• Subjects must be able to communicate effectively with the study staff and to understand study instructions (not applicable for toddlers and preschoolers)

You may not qualify if…

• Any skin or muscular condition, such as eczema, scars, infections, moles, or tattoos at the site of measurements
• Allergy to ultrasound gel
• 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
• Is an employee or authorized representative of CROSSJECT SA or ICON plc
• Adult under guardianship or subject incarcerated

Where it is running

• Clinical Trials of Texas, LLC dba Flourish Research — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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