Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-27 @ 12:05 PM
Study NCT ID:
NCT03056066
Status:
UNKNOWN
Last Update Posted:
2018-05-01
First Post:
2017-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-29', 'studyFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device', 'timeFrame': 'September 2017', 'description': 'The primary outcome of the FRC and air way resistance of the Spircare device against the plethysmograph will be displayed as scatter plot. A linear regression and the R2 value will be display as well. The associated Bland-Altman plots comparing the FRC and airway resistance of the Spircare device to the plethysmograph with lines that represent width of 0.1 (±1.96\\*SD).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD Asthma', 'Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Phase I Health subjects without respiratory system disease.\n\nPhase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed consent.\n2. Age≥18 year.\n3. Subject is cooperative and capable of following instructions.\n4. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.\n5. Phase II: Chronic pulmonary patients with lung volume disorders:\n\n * COPD\n * Asthma\n * Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.\n\nExclusion Criteria:\n\n1. Subjects unable or unwilling to give informed consent.\n2. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).\n3. History suggesting upper respiratory infection during the four weeks prior to testing\n4. Physical activity during 1 hour prior to the Study.\n5. Patients with a tracheostomy.\n6. Pregnant women.'}, 'identificationModule': {'nctId': 'NCT03056066', 'briefTitle': 'Accuracy of Spircare Device as Compared to the Conventional Plethysmograph', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spircare Ltd.'}, 'officialTitle': 'Accuracy of Spircare Device as Compared to the Conventional Plethysmograph', 'orgStudyIdInfo': {'id': 'DA-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Plethysmograph', 'type': 'DEVICE', 'description': 'A full Body Plethysmography examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': '"Meir" Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spircare Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}