Ultrasound evaluation of muscle and skin characteristics in healthy individuals
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 study is testing how ultrasound can help us understand the muscle and skin layers in healthy adults and children aged 2 to 17 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 2 Years to 70 Years |
| Sex | All |
| Sponsor | Crossject Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06279689 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to assess the anatomical characteristics of the anterolateral thighs in both healthy adults and children aged 2 to 17 years using ultrasound scans. It will also evaluate the deltoid and upper arm muscles in healthy adults. The study involves a single on-site visit where ultrasound scans will be performed before and during the application of a force similar to the ZENEO® triggering force. The primary focus is on measuring skin-to-muscle and skin-to-bone distances, as well as the thickness of skin and muscle layers.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 2 to 70 years who are in stable health and meet specific BMI criteria.
Not a fit: Patients with skin or muscular conditions at the measurement sites or those with significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of muscle and skin anatomy, potentially informing future medical applications.
How similar studies have performed: While similar studies have explored ultrasound applications, this specific approach focusing on anatomical characteristics in healthy populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas
- Clinical Trials of Texas, LLC dba Flourish Research — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Olivier LACOMBE
- Email: o.lacombe@crossject.com
- Phone: +33617685235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.