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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04515251
Other study ID # RAD-SMA-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 27, 2020
Est. completion date December 30, 2024

Study information

Verified date September 2023
Source Ente Ospedaliero Cantonale, Bellinzona
Contact Marirosa Cristallo Lacalamita, MD
Phone +41 (0)91 811 84 75
Email Marirosa.CristalloLacalamita@eoc.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 289
Est. completion date December 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 15 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound measurements
ultrasound measurement at the level of the left renal vein on a sagittal plane according to age

Locations

Country Name City State
Switzerland Imaging Institute of Southern Switzerland Bellinzona
Switzerland Hôpitaux Universitaires Genève Geneva

Sponsors (2)

Lead Sponsor Collaborator
Ente Ospedaliero Cantonale, Bellinzona Imaging Institute of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Define the normal range of values of the SMA angle Measurement in degree with its 95% confidence interval 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary Assess the association between the SMA angle and BMI categories According to age and sex. 1 day
See also
  Status Clinical Trial Phase
Completed NCT03416647 - SMAS: a Prospective Study in a Single Institution N/A