NCT04515251

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2020Dec 2026

Study Start

First participant enrolled

April 27, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

6.7 years

First QC Date

August 13, 2020

Last Update Submit

July 30, 2025

Conditions

Superior Mesenteric Artery Syndrome

Outcome Measures

Primary Outcomes (1)

  • Define the normal range of values of the SMA angle

    Measurement in degree with its 95% confidence interval

    1 day

Secondary Outcomes (4)

  • Define the normal range of values of the SMA-A distance LV

    1 day

  • Define the normal range of values of the SMA-A distance D

    1 day

  • Define the normal range of values of the SMA angle (degree), SMA-A distance LV

    1 day

  • Assess the association between the SMA angle and BMI categories

    1 day

Interventions

Ultrasound measurementsDIAGNOSTIC_TEST

ultrasound measurement at the level of the left renal vein on a sagittal plane according to age

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged from 10 to 15 years

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imaging Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

RECRUITING

Hôpitaux Universitaires Genève

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Superior Mesenteric Artery Syndrome

Condition Hierarchy (Ancestors)

Duodenal ObstructionDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Marirosa Cristallo Lacalamita, MD

    Imaging Institute of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marirosa Cristallo Lacalamita, MD

CONTACT

+41 (0)91 811 84 75Marirosa.CristalloLacalamita@eoc.ch

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Principal investigator

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

April 27, 2020

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)