Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT01225367
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2010-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2010-10-19', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Pathologies', 'Cardio-pulmonary Diseases']}, 'descriptionModule': {'briefSummary': 'The study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system.\n\nThe system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18y or older\n* patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease\n* Patients with CHF\n* Patients with pulmonary hypertension\n* Patients with COPD\n* Patients with Asthma\n* Signed informed consent\n* Normal subjects\n\nExclusion Criteria:\n\n* Patients with unstable conditions: unstable angina, uncontrolled CHF, etc\n* Inability to assume a sitting or supine position\n* Patients with severe chest wall deformity'}, 'identificationModule': {'nctId': 'NCT01225367', 'briefTitle': 'The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Echosense Ltd.'}, 'officialTitle': 'Detection and Characterization of Cardio-pulmonary Patho-physiological States and Diseases by Ultrasound Transthoracic Doppler', 'orgStudyIdInfo': {'id': 'ES_DOP05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pulmonary doppler', 'interventionNames': ['Device: ultrasound doppler monitoring']}], 'interventions': [{'name': 'ultrasound doppler monitoring', 'type': 'DEVICE', 'description': 'Regular noninvasive chest echo monitoring', 'armGroupLabels': ['pulmonary doppler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31064', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Elisha hospital', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Moshe Person, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elisha Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Echosense Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}