Healthy SubjectsNCT06279689
Echography Study_Anthropometric Measurements
A study testing Ultrasound scans in people with Healthy Subjects, run by Crossject at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Ultrasound scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229
Maya Adair, 210-949-0122 ext. 200, madair@flourishresearch.com
Nathan Cortez, 2109490122 ext. 108, ncortez@flourishresearch.com
About this study
Official title: 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 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.
Read the detailed description
The exploratory endpoints are as follows:
- The skin-to-muscle distance (STMD) (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- The skin-to-bone distance (STBD) (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- The thickness of skin layers (mm) (thickness of dermis, thickness of hypodermis [ie, subcutaneous fat]) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- The thickness of muscle layers (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- Conditions
- Healthy Subjects
- Being tested
- Ultrasound scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scansOther
Ultrasound scans connected with an application enabling the measurement of the force applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ultrasound scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
STBD : Skin To Bone Distance
Distance measurement
Measured: Day1
STMD: Skin To Muscle Distance
Distance measurement
Measured: Day1
Thickness of skin layers (dermis, hypodermis)
Thickness measurement
Measured: Day1
Thickness of muscle layers
Thickness measurement
Measured: Day1
Secondary outcomes (1)
Circumferences measurements (thigh, upper arm, waist, hip)
Measurement
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start13 Feb 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crossject
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathalie LOUGHRAIEB, Study director, Crossject
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279689
- Sponsor's protocol ID
- CJTCDZ2301
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06279689
- Acronym / sponsor ID
- CJTCDZ2301
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CrossjectIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The exploratory endpoints are as follows:
- The skin-to-muscle distance (STMD) (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- The skin-to-bone distance (STBD) (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- The thickness of skin layers (mm) (thickness of dermis, thickness of hypodermis [ie, subcutaneous fat]) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
- The thickness of muscle layers (mm) before and while applying a force on both anterolateral thighs, one shoulder (deltoid), and one upper arm (biceps and triceps) in the adult population and both anterolateral thighs in the pediatric population
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects : Adult and pediatric populations | Experimental | Other: Ultrasound scansOnly 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. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scansUltrasound scans connected with an application enabling the measurement of the force applied. | Other | Healthy subjects : Adult and pediatric populations |
Primary outcome
STBD : Skin To Bone Distance
Time frame: Day1
Distance measurement
STMD: Skin To Muscle Distance
Time frame: Day1
Distance measurement
Thickness of skin layers (dermis, hypodermis)
Time frame: Day1
Thickness measurement
Thickness of muscle layers
Time frame: Day1
Thickness measurement
1 secondary outcome
Circumferences measurements (thigh, upper arm, waist, hip)
Time frame: Day1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie LOUGHRAIEB study director
Crossject
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound scans in people with Healthy Subjects, run by Crossject at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier LACOMBE (+33617685235, o.lacombe@crossject.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STBD : Skin To Bone Distance (time frame: Day1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.