Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT02228018
Status:
WITHDRAWN
Last Update Posted:
2016-02-03
First Post:
2014-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Other strategies followed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-08-26', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CALSA', 'timeFrame': '1 day', 'description': 'The primary objective of this study is to compare CALSA with FRI. The respiratory sounds recordings are performed with a digital stethoscope and connected to the sound card of a laptop with commercial software, suitable for data acquisition. The respiratory sounds recordings are conducted in accordance with the Computerized Respiratory Sound Analysis guidelines (CORSA) for short-term acquisition. Subjects are asked to breathe through the mouth in a sitting position (tidal breathing) during the recordings. Three sets of recordings are made for 7 - 10 respiratory cycles with a maximum duration of 25 seconds.'}], 'secondaryOutcomes': [{'measure': 'Total Airway Volume (iVaw)', 'timeFrame': '1 day', 'description': 'The secondary objective is to check the repeatability of the FRI parameters'}, {'measure': 'Total Airway Resistance (iRaw)', 'timeFrame': '1 day', 'description': 'The secondary objective is to check the repeatability of the FRI parameters.'}, {'measure': 'Internal Airway Distribution', 'timeFrame': '1 day', 'description': 'The secondary objective is to check the repeatability of the FRI parameters'}, {'measure': 'Lobar Volume', 'timeFrame': '1 day', 'description': 'The secondary objective is to check the repeatability of the FRI parameters'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.', 'detailedDescription': 'his is a study with no investigational product. CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.\n\nElectronic auscultation of respiratory sounds will be performed, lung function tests (at maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be taken. The scans will be taken at two different breathing levels, more specifically at total lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be taken.\n\nThe objective of this study is to compare CALSA with FRI and to assess the repeatability of FRI biomarkers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient / volunteer ≥ 18 years old\n* Written informed consent obtained\n* The subject belongs to 1 of the following groups in the opinion of the investigator:\n\nGroup 1: healthy volunteer Group 2: patient with asthma\n\n* Only if patient/ volunteer is a female of childbearing potential: Confirmation that a contraception method was used at least 14 days before visit 1\n\nExclusion Criteria:\n\n* Pregnant or lactating female\n* Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.\n\nPatient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.'}, 'identificationModule': {'nctId': 'NCT02228018', 'briefTitle': 'The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'FLUIDDA nv'}, 'officialTitle': 'The Comparison of Electronic Auscultation Coupled With Computer Aided Lung Sound Analysis (CALSA) and Functional Respiratory Imaging (FRI) and Repeatability of FRI Biomarkers in Healthy Subjects and Asthma Patients', 'orgStudyIdInfo': {'id': 'FLUI-2014-118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CALSA and FRI repeatability', 'description': 'CT-Scan No medication used', 'interventionNames': ['Device: CT-scan']}], 'interventions': [{'name': 'CT-scan', 'type': 'DEVICE', 'description': 'CT-Scan will be taken at visit 1 on FRC and TLC breathing levels', 'armGroupLabels': ['CALSA and FRI repeatability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'overallOfficials': [{'name': 'Wilfried De Backer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FLUIDDA nv', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}