Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 4:36 AM
Study NCT ID:
NCT07046793
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 815}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-06-29', 'studyFirstSubmitQcDate': '2025-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture yes/no as final diagnosis', 'timeFrame': 'at 4 weeks from inclusion'}, {'measure': 'Possible unstable fracture as final diagnosis', 'timeFrame': '4 weeks from inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fractures in Children']}, 'descriptionModule': {'briefSummary': 'This is a multicenter combined diagnostic accuracy study and observational prospective cohort.\n\nPart one aims to confirm non-inferiority of POCUS for the detection of distal forearm fractures compared to X-ray.\n\nPart two aims to confirm non-inforiority of POCUS compared to x-ray for the detection of potentially unstable forearm fractures needing follow up imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with wrist trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to the emergency room of a study hospital with an acute trauma to the wrist and suspected fracture of the wrist consulted by a trained study examiner.\n* Age 0-18 years Depending on the result\n\nExclusion Criteria:\n\n* Patient needing immediate medical attention (triage score 1 or 2) as well as severely displaced or open fractures or neurovascular compromise distally to the suspected fracture.\n* Patient with imaging studies obtained prior to the emergency room visit\n* Patient with prior fracture of the affected wrist within the last 24 months\n* Patient refusing participation / missing informed consent.'}, 'identificationModule': {'nctId': 'NCT07046793', 'acronym': 'FRUSKI-Wrist', 'briefTitle': 'Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital Basel"}, 'officialTitle': 'Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)', 'orgStudyIdInfo': {'id': '2022-00376'}}, 'armsInterventionsModule': {'interventions': [{'name': 'POCUS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound screening of the distal forearm.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Kinderspital zentralschweiz', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Troxler', 'class': 'OTHER'}, 'collaborators': [{'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'La Tour Hospital', 'class': 'OTHER'}, {'name': 'Hôpital Fribourgeois', 'class': 'OTHER'}, {'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor Investigator', 'investigatorFullName': 'David Troxler', 'investigatorAffiliation': "University Children's Hospital Basel"}}}}