NCT06279689 Echography Study_Anthropometric Measurements
| NCT ID | NCT06279689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Crossject |
| Condition | Healthy Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-13 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-02-13 with a primary completion date of 2024-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Nathalie LOUGHRAIEB
STUDY DIRECTOR
Crossject
Frequently Asked Questions
Who can join the NCT06279689 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 70 Years, studying Healthy Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06279689 currently recruiting?
Yes, NCT06279689 is actively recruiting participants. Contact the research team at o.lacombe@crossject.com for enrollment information.
Where is the NCT06279689 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT06279689 clinical trial?
NCT06279689 is sponsored by Crossject. The principal investigator is Nathalie LOUGHRAIEB at Crossject. The trial plans to enroll 90 participants.