Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-30 @ 6:21 PM
Study NCT ID:
NCT02165969
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2014-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olfactory Function Following Endoscopic Endonasal Skull Base Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-12', 'releaseDate': '2018-03-07'}, {'resetDate': '2021-03-25', 'releaseDate': '2021-03-02'}, {'resetDate': '2021-11-12', 'releaseDate': '2021-10-17'}, {'resetDate': '2024-08-09', 'releaseDate': '2024-03-07'}, {'resetDate': '2025-11-10', 'releaseDate': '2025-10-23'}, {'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2018-03-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2014-05-23', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with decreased olfactory function after endoscopic endonasal surgery', 'timeFrame': 'up to 12 months post surgery', 'description': 'The subject will complete 2 questionnaires and the University of Pennsylvania Smell Identification Test (UPSIT) at baseline (pre-surgery) and at 1, 3, 6, and 12, months post surgery to determine if the sense of smell has been altered from surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tumor', 'inflammatory process', 'fracture', 'defect'], 'conditions': ['Skull Base Pathology']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare a subject's sense of smell before and after endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory process, fracture, defect, etc.) and use the information collected to validate approaches to surgery that will minimize side effects to the sense of smell function. Data will be collected using a smell identification test along with two questionnaires. In addition, demographic, medical history, treatment, outcome, and follow-up information will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with skull base pathologies requiring endonasal surgery at The Ohio State University Wexner Medical Center\n* 18 years or older\n* Able to consent for self\n* Negative serum pregnancy test for women of childbearing potential\n\nExclusion Criteria:\n\n* Patient unable to return to clinic at specific follow-up times\n* Pregnant or nursing\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT02165969', 'acronym': 'UPSIT', 'briefTitle': 'Olfactory Function Following Endoscopic Endonasal Skull Base Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Olfactory Function Following Endoscopic Endonasal Skull Base Surgery: Clinical and Histological Outcomes', 'orgStudyIdInfo': {'id': '2014H0063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'endoscopic endonasal surgery with UPSIT', 'description': 'endoscopic endonasal surgery with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery.', 'interventionNames': ['Procedure: endoscopic endonasal surgery with UPSIT']}], 'interventions': [{'name': 'endoscopic endonasal surgery with UPSIT', 'type': 'PROCEDURE', 'armGroupLabels': ['endoscopic endonasal surgery with UPSIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda McGill, MS', 'role': 'CONTACT', 'email': 'Amanda.McGill@osumc.edu', 'phone': '614-685-8622'}, {'name': 'Ricardo Carrau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Amanda McGill, MA', 'role': 'CONTACT', 'email': 'Amanda.McGill@osumc.edu', 'phone': '614-685-8622'}], 'overallOfficials': [{'name': 'Ricardo Carrau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ricardo L. Carrau, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ricardo L. Carrau, MD', 'investigatorAffiliation': 'Ohio State University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-03-07', 'type': 'RELEASE'}, {'date': '2018-10-12', 'type': 'RESET'}, {'date': '2021-03-02', 'type': 'RELEASE'}, {'date': '2021-03-25', 'type': 'RESET'}, {'date': '2021-10-17', 'type': 'RELEASE'}, {'date': '2021-11-12', 'type': 'RESET'}, {'date': '2024-03-07', 'type': 'RELEASE'}, {'date': '2024-08-09', 'type': 'RESET'}, {'date': '2025-10-23', 'type': 'RELEASE'}, {'date': '2025-11-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ricardo L. Carrau, MD, Professor, The Ohio State University'}}}}