Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-28 @ 11:17 PM
Study NCT ID:
NCT00672893
Status:
COMPLETED
Last Update Posted:
2009-06-16
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D000402', 'term': 'Airway Obstruction'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-15', 'studyFirstSubmitDate': '2008-05-01', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.', 'timeFrame': 'Baseline and follow-up up to 3 months'}], 'secondaryOutcomes': [{'measure': 'The secondary objective is to assess the contribution of the VRI in aiding in identification of the pulmonary obstruction as compared to the standard methods prior the intervention procedure.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment'], 'conditions': ['Central Airway Stenosis']}, 'referencesModule': {'references': [{'pmid': '17551264', 'type': 'BACKGROUND', 'citation': 'Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.'}, {'pmid': '15187010', 'type': 'BACKGROUND', 'citation': 'Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.'}]}, 'descriptionModule': {'briefSummary': "Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.\n\nAs obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the age range of 18-85 and consisting of both male and females, who present to the clinic with airway obstruction and who are designated to undergo intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.\n* Male or female in the age range of 18-85 years.\n* Body Mass Index \\>20.\n* Patient presented with airway obstruction and who are designated to undergo intervention\n\nExclusion Criteria:\n\n* Chest wall deformity;\n* Spine deformity (including severe scoliosis or kyphosis);\n* Hirsutism;\n* Potentially contagious skin lesion on the back;\n* Skin lesion that would interfere with sensor placement;\n* Patient is pregnant;\n* Cardiac pacemaker or implantable defibrillator;'}, 'identificationModule': {'nctId': 'NCT00672893', 'briefTitle': 'Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Deep Breeze'}, 'officialTitle': 'Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure', 'orgStudyIdInfo': {'id': 'DB035-Multi-site'}, 'secondaryIdInfos': [{'id': 'DB020-Single-site'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'Patients who present to the clinic with airway obstruction and who are designated to undergo intervention', 'interventionNames': ['Other: Vibration Response Imaging']}], 'interventions': [{'name': 'Vibration Response Imaging', 'type': 'OTHER', 'description': '12 seconds of recording lung sounds', 'armGroupLabels': ['Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80602', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Medical and Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'Hospital St. Marguerite', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': 'D-69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik at Heidelberg University', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '216-8511', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}], 'overallOfficials': [{'name': 'Heinrich D Becker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik at Heidelberg University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deep Breeze', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Prof. Heinrich D. Becker, MD', 'oldOrganization': 'Thoraxklinik at Heidelberg University'}}}}