Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-02 @ 6:17 AM
Study NCT ID:
NCT00426569
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2007-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Paranasal Sinuses Microflora Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2007-01-23', 'studyFirstSubmitQcDate': '2007-01-23', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of bacteria in normal paranasal sinuses', 'timeFrame': 'at time of orthgnatic surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Paranasal Sinuses', 'Flora']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to check if bacterial and fungal flora exists in healthy paranasal sinuses, and whether it is identical to the flora of nasal cavity.\n\nWe plan to harvest tiny examples of maxillary sinus and nasal mucosa for tissue cultures during the orthognathic procedures involving maxillary remodeling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults undergoing orthognatic procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Necessity of maxillary sinus opening during orthognathic surgery\n* Negative history of chronic rhinitis or chronic sinusitis\n* Informed concent\n\nExclusion Criteria:\n\n* Recent(1 month or less before the operation) event of acute sinusitis or other disease leading to nasal discharge\n* Recent(1 month or less before the operation) antibacterial or antifungal parenteral treatment'}, 'identificationModule': {'nctId': 'NCT00426569', 'briefTitle': 'Normal Paranasal Sinuses Microflora Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'orgStudyIdInfo': {'id': 'SHEBA-07-4534-AY-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Arkadi Yakirevitch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sheba Medical Center, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Arkadi Yakirevitch, MD', 'investigatorFullName': 'Dr. Arkadi Yakirevitch', 'investigatorAffiliation': 'Sheba Medical Center'}}}}