Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT02854969
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction through a questionnaire in the use of the medical device', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Medical device safety', 'timeFrame': '3 months', 'description': 'Adverse events related to the medical device'}, {'measure': 'Patient Adherence to the medical device through a questionnaire', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anaphylaxis']}, 'descriptionModule': {'briefSummary': 'Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years old or above\n* Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed\n* Patients with a smartphone\n* Patients who signed the informed consent\n\nExclusion Criteria:\n\n* Patients who have not signed the informed consent\n* Patients with some limitations for understanding or following correctly the trial procedures\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT02854969', 'briefTitle': 'Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adan Medical Innovation, SL'}, 'officialTitle': 'Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis', 'orgStudyIdInfo': {'id': 'AnapphylaxisQoL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'epinephrine auto-injector', 'description': '3 months using the epinephrine auto-injector alone, and after that 3 more months using the epinephrine auto-injector + medical device'}, {'type': 'EXPERIMENTAL', 'label': 'epinephrine auto-injector + medical device', 'description': 'Device: Anapphylaxis is a medical device with a case for an epinephrine autoinjector that connects via Bluetooth to a mobile application\n\n3 months using the epinephrine auto-injector + medical device , and after that 3 more months using the epinephrine auto-injector alone', 'interventionNames': ['Behavioral: Device: Anapphylaxis']}], 'interventions': [{'name': 'Device: Anapphylaxis', 'type': 'BEHAVIORAL', 'armGroupLabels': ['epinephrine auto-injector + medical device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adan Medical Innovation, SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}