Superior Mesenteric Artery SyndromeNCT04515251
Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
An observational study of Superior Mesenteric Artery Syndrome, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in Switzerland.
Trial summary
Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Superior Mesenteric Artery Syndrome
- What is being tested?
- Ultrasound measurements
- How many people
- 289 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 27 Apr 2020to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged from 10 to 15 years
Who may be able to join
- Male and female children
- Age ranging from10 to 15 years, included
- Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
- Signed Informed Consent
Who cannot join
- Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
- Oncologic patients at risk of neoplastic cachexia.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Imaging Institute of Southern Switzerland
Bellinzona, 6500
Marirosa Cristallo Lacalamita, MD, +41 (0)91 811 84 75, Marirosa.CristalloLacalamita@eoc.ch
- Recruiting
Hôpitaux Universitaires Genève
Geneva, 1205
Sylviane Hanquinet, Prof, +41 (0)22 372 70 36, Sylviane.Hanquinet-Ginter@hcuge.ch
About this study
Official title: A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.
Read the detailed description
Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.
- Conditions
- Superior Mesenteric Artery Syndrome
- Being tested
- Ultrasound measurements
- Medical subject headings
- Superior Mesenteric Artery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurementsDiagnostic test
ultrasound measurement at the level of the left renal vein on a sagittal plane according to age
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the normal range of values of the SMA angle
Measurement in degree with its 95% confidence interval
Measured: 1 day
Secondary outcomes (4)
Define the normal range of values of the SMA-A distance LV
Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination at the level of the left renal vein on an axial plane according to age
Measured: 1 day
Define the normal range of values of the SMA-A distance D
Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination at a level where the third part of the duodenum crosses on an axial plane according to age
Measured: 1 day
Define the normal range of values of the SMA angle (degree), SMA-A distance LV
Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination according to BMI categories, subcutaneous and visceral fat thickness
Measured: 1 day
Assess the association between the SMA angle and BMI categories
According to age and sex.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start27 Apr 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Mesenteric Artery SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Collaborators
- Imaging Institute of Southern Switzerland
- Responsible party
- Principal investigator, Marirosa Cristallo Lacalamita, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Marirosa Cristallo Lacalamita, MD, Principal investigator, Imaging Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515251
- Sponsor's protocol ID
- RAD-SMA-001
- Status last verified
- Jul 2025
- First submitted
- 13 Aug 2020
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
- ClinicalTrials.gov ID
- NCT04515251
- Acronym / sponsor ID
- RAD-SMA-001
- Conditions
- Superior Mesenteric Artery Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Collaborators
- Imaging Institute of Southern Switzerland
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Aug 2020 (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.
Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.
Detailed description
Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged from 10 to 15 years
Key inclusion criteria (4 listed)
- Male and female children
- Age ranging from10 to 15 years, included
- Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
- Signed Informed Consent
Key exclusion criteria (2 listed)
- Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
- Oncologic patients at risk of neoplastic cachexia.
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 measurementsultrasound measurement at the level of the left renal vein on a sagittal plane according to age | Diagnostic test | – |
Primary outcome
Define the normal range of values of the SMA angle
Time frame: 1 day
Measurement in degree with its 95% confidence interval
4 secondary outcomes
Define the normal range of values of the SMA-A distance LV
Time frame: 1 day
Define the normal range of values of the SMA-A distance D
Time frame: 1 day
Define the normal range of values of the SMA angle (degree), SMA-A distance LV
Time frame: 1 day
Assess the association between the SMA angle and BMI categories
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- 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.
Marirosa Cristallo Lacalamita, MD principal investigator
Imaging Institute of Southern Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Mesenteric Artery Syndrome, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in Switzerland.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marirosa Cristallo Lacalamita, MD (+41 (0)91 811 84 75, Marirosa.CristalloLacalamita@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the normal range of values of the SMA angle (time frame: 1 day). 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 31 Jul 2025.