Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT02924103
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2016-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contamination Free Bacterial Swap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of staphylococcus aureus positive cultures', 'timeFrame': '1 year', 'description': 'Comparison of the frequency of staphylococcus aureus positive cultures from the two sides of the nose'}], 'secondaryOutcomes': [{'measure': 'Frequency of other bacteria in cultures', 'timeFrame': '1 year', 'description': 'Comparison of the frequency of other positive cultures from the two sides of the nose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute rhinosinusitis', 'staphylococcus aureus', 'nasal vestibule', 'contamination'], 'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': 'A test of a newly designed device (Contamination free bacterial swab). This device can be used to introduce a standard bacterial swab into the nose without direct or indirect contact with the nasal vestibule.', 'detailedDescription': 'Aim:\n\nThe investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.\n\nMore precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.\n\nThe overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.\n\nDesign:\n\nA comparative study in which patients serve as their own control. A bacterial swab will be introduced to both sides of the nose; on the right side using the new device, on the left side using the present day technique (visual guidance). 70 participants will be included.\n\nStatistics:\n\nA chi-square test will be used for comparison of frequencies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptoms of upper airway disease\n\nExclusion Criteria:\n\n* mental illness\n* Need for interpreter'}, 'identificationModule': {'nctId': 'NCT02924103', 'briefTitle': 'Contamination Free Bacterial Swap', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)', 'orgStudyIdInfo': {'id': 'CIV-16-04-015264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Right side', 'description': 'All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy), will be introduced to both sides of the nose (to the middle meatus); on the RIGHT side by using the "Contamination free bacterial swab" introduction device.\n\nThe "Contamination free bacterial swab" introduction device is a prototype developed for clinical testing.', 'interventionNames': ['Device: Contamination free bacterial swab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left side', 'description': 'All included participants serve as their own control. A bacterial swab (Eswab 481CE, Copan Diagnostics, Italy) will be introduced to both sides of the nose (to the middle meatus); on the LEFT side using the present day clinical procedure (visually guided introduction).', 'interventionNames': ['Device: Contamination free bacterial swab']}], 'interventions': [{'name': 'Contamination free bacterial swab', 'type': 'DEVICE', 'description': 'A comparison of the bacteriology in bacterial swabs (Eswab 481CE, Copan Diagnostics, Italy) from the middle meatus. On the RIGHT side using the "Contamination free bacterial swab" introduction device that facilitates the introduction of a bacterial swab into the nose without direct or indirect contact with the nasal vestibule.', 'armGroupLabels': ['Left side', 'Right side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Ørelæge Steffen Ørntoft', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Steffen Ørntoft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steffen Ørntoft, Ear, Nose and Throat specialist clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kåre Håkansson', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Capital Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D', 'investigatorFullName': 'Kåre Håkansson', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}