Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-27 @ 10:54 AM
Study NCT ID:
NCT06311292
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No parties will be prevented from having knowledge of the Volara System use.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sufficient sputum quantity for a pellet', 'timeFrame': '10 minutes', 'description': 'Percentage of patients with a successful culture result from sputum'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.\n\nParticipants will use the Volara System during clinic visit in an attempt to produce sputum.', 'detailedDescription': 'Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care.\n\nThe purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older\n2. 2\\. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.\n\n2\\. No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771\n\nExclusion Criteria:\n\n1. \\< 18 years old\n2. Sputum culture results in last one year'}, 'identificationModule': {'nctId': 'NCT06311292', 'briefTitle': 'Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'STUDY22090138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrapulmonary Percussive Ventilation for Non-sputum Producer', 'description': 'Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.', 'interventionNames': ['Device: Volara System']}], 'interventions': [{'name': 'Volara System', 'type': 'DEVICE', 'description': 'Intrapulmonary percussive ventilation for mobilizing mucus.', 'armGroupLabels': ['Intrapulmonary Percussive Ventilation for Non-sputum Producer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Daniel Weiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UPMC Children's Hospital of Pittsburgh"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests.\n\nSpecimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniel J. Weiner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics and Pediatric Pulmonologist', 'investigatorFullName': 'Daniel J. Weiner', 'investigatorAffiliation': 'University of Pittsburgh'}}}}