Echography Study_Anthropometric Measurements

NCT06279689 | Recruiting

• 1 other identifier: CJTCDZ2301
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Circumferences measurements (thigh, upper arm, waist, hip)

  Day1

Study Arms (1)

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.

Other: Ultrasound scans

Interventions

Ultrasound scans OTHER

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

Healthy subjects : Adult and pediatric populations

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Crossject: lead

Study Sites (1)

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

• Nathalie LOUGHRAIEB

  Crossject

  STUDY DIRECTOR

Central Study Contacts

Olivier LACOMBE

CONTACT

+33617685235; o.lacombe@crossject.com

Nathalie Loughraieb

CONTACT

+33380549850; n.loughraieb@crossject.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 28, 2024
• Study Start: February 13, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)