Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 5:16 PM
Study NCT ID:
NCT00901433
Status:
COMPLETED
Last Update Posted:
2009-06-24
First Post:
2009-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-23', 'studyFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2009-05-11', 'lastUpdatePostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety will be evaluated by success rate of task performance.', 'timeFrame': 'At the end of the study meeting'}], 'secondaryOutcomes': [{'measure': 'Number of questions addressed to the investigator required by the participant in order to complete tasks.', 'timeFrame': 'during the study'}, {'measure': 'User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems.', 'timeFrame': 'At the end of the study meeting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Wheeze Rate', 'Respiratory Function Tests'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. Furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty.\n\nKarmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. This usability study was designed to test independent home use and device interface effectiveness of the Personal WheezoMeter in order to validate its safe and effective use by intended users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male/Female participants ages 18 and up that were either diagnosed as an asthmatic or are parent/guardian of an asthmatic child age under 18 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female age 18 years and up.\n* Subject is diagnosed as an asthmatic, or subject is parent/guardian of an asthmatic child age under 18 years.\n* Subject understands the study procedure.\n* Subject is able to read the User Manual.\n* Signed Informed Consent form\n* Compliance with study requirements.\n\nExclusion Criteria:\n\n* Major physical, motor, mental, behavioral, or psychiatric limitations.\n* Concurrent additional major illness.\n* Subject objects to the study protocol.'}, 'identificationModule': {'nctId': 'NCT00901433', 'briefTitle': 'Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'KarmelSonix Ltd.'}, 'officialTitle': 'Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study', 'orgStudyIdInfo': {'id': 'KSI-PW-US-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Usability study of the Personal Wheezometer', 'interventionNames': ['Device: Personal WheezoMeter']}], 'interventions': [{'name': 'Personal WheezoMeter', 'type': 'DEVICE', 'description': 'pulmonary sounds analyzer', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'RAMBAM Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Hanna Levy, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KarmelSonix Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KarmelSonix Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Hanna Levy - Director of clinical studies', 'oldOrganization': 'KarmelSonix Ltd'}}}}