Ultrasound Evaluation of Superior Mesenteric Artery Measu... | NCT04515251

Studies
Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population

NCT04515251

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Status

Recruiting

Last Update Posted

Jul 31, 2025Actual

Enrollment

289Estimated

Phase

Not provided

Conditions

Superior Mesenteric Artery Syndrome

Interventions

Ultrasound measurements

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2020Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Aug 13, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2025

Last Update Posted Date

Jul 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marirosa Cristallo Lacalamita, MD Principal investigator, Ente Ospedaliero Cantonale, BellinzonaPrincipal Investigator

Lead Sponsor

Ente Ospedaliero Cantonale, BellinzonaOTHER

Collaborators

Name	Class
Imaging Institute of Southern Switzerland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

289Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound measurements	Diagnostic Test	ultrasound measurement at the level of the left renal vein on a sagittal plane according to age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Define the normal range of values of the SMA angle	Measurement in degree with its 95% confidence interval	1 day

Secondary Outcomes

Measure	Description	Time Frame
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
Define the normal range of values of the SMA-A distance D

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Children aged from 10 to 15 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marirosa Cristallo Lacalamita, MD	Contact	+41 (0)91 811 84 75		Marirosa.CristalloLacalamita@eoc.ch

Overall Officials

Name	Affiliation	Role
Marirosa Cristallo Lacalamita, MD	Imaging Institute of Southern Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imaging Institute of Southern Switzerland	Recruiting	Bellinzona		6500	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013478	Superior Mesenteric Artery Syndrome

Ancestor Terms

ID	Term
D004380	Duodenal Obstruction
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

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Browse Branches

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