NCT06279689 · Crossject
Echography Study_Anthropometric Measurements
What this study is about
This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no experimental 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 treatment group$1 (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 experimental 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2024 · Source of record for eligibility and locations