Echography Study_Anthropometric Measurements

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Crossject
Study ID
NCT06279689
Status
Recruiting

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
2 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Ultrasound scans — OTHER
    Ultrasound scans connected with an application enabling the measurement of the force applied.

Study Details

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 Dates

Start date
Feb 13, 2024
Status verified
Jul 2024
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

STBD : Skin To Bone Distance [ Time Frame: Day1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trials of Texas, LLC dba Flourish ResearchSan AntonioTexas78229
Maya Adair
210-949-0122
Nathan Cortez
2109490122

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