Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-04 @ 5:40 PM
Study NCT ID:
NCT04515251
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2020-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013478', 'term': 'Superior Mesenteric Artery Syndrome'}], 'ancestors': [{'id': 'D004380', 'term': 'Duodenal Obstruction'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 289}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define the normal range of values of the SMA angle', 'timeFrame': '1 day', 'description': 'Measurement in degree with its 95% confidence interval'}], 'secondaryOutcomes': [{'measure': 'Define the normal range of values of the SMA-A distance LV', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Define the normal range of values of the SMA-A distance D', 'timeFrame': '1 day', 'description': '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'}, {'measure': 'Define the normal range of values of the SMA angle (degree), SMA-A distance LV', 'timeFrame': '1 day', 'description': 'Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination according to BMI categories, subcutaneous and visceral fat thickness'}, {'measure': 'Assess the association between the SMA angle and BMI categories', 'timeFrame': '1 day', 'description': 'According to age and sex.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Superior Mesenteric Artery Syndrome']}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged from 10 to 15 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female children\n* Age ranging from10 to 15 years, included\n* Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)\n* Oncologic patients at risk of neoplastic cachexia.'}, 'identificationModule': {'nctId': 'NCT04515251', 'briefTitle': 'Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': 'A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population', 'orgStudyIdInfo': {'id': 'RAD-SMA-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'ultrasound measurement at the level of the left renal vein on a sagittal plane according to age'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Bellinzona', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Marirosa Cristallo Lacalamita, MD', 'role': 'CONTACT', 'email': 'Marirosa.CristalloLacalamita@eoc.ch', 'phone': '+41 (0)91 811 84 75'}], 'facility': 'Imaging Institute of Southern Switzerland', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sylviane Hanquinet, Prof', 'role': 'CONTACT', 'email': 'Sylviane.Hanquinet-Ginter@hcuge.ch', 'phone': '+41 (0)22 372 70 36'}], 'facility': 'Hôpitaux Universitaires Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Marirosa Cristallo Lacalamita, MD', 'role': 'CONTACT', 'email': 'Marirosa.CristalloLacalamita@eoc.ch', 'phone': '+41 (0)91 811 84 75'}], 'overallOfficials': [{'name': 'Marirosa Cristallo Lacalamita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imaging Institute of Southern Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ente Ospedaliero Cantonale, Bellinzona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imaging Institute of Southern Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Principal investigator', 'investigatorFullName': 'Marirosa Cristallo Lacalamita', 'investigatorAffiliation': 'Ente Ospedaliero Cantonale, Bellinzona'}}}}