Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-27 @ 1:11 AM
Study NCT ID:
NCT01054703
Status:
TERMINATED
Last Update Posted:
2024-08-06
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Ethmoid Sinus Spacer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lenglan1@its.jnj.com', 'phone': '650-687-4466', 'title': 'Laura England, Manager-Clinical Research', 'organization': 'Acclarent'}, 'certainAgreement': {'otherDetails': 'Principal investigator shall not issue or disseminate any press release or statement, nor initiate or cause to be initiated any communication of information regarding the clinical trial (written or oral) to the communications media or third parties without the prior written consent of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ethmoid Sinus Spacer Placement', 'description': 'Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ethmoid Sinus Spacer Placement', 'description': 'Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Procedural and 6 weeks post-implant', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures', 'timeFrame': '1 wk, 2wk, 4wk, 6wk', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ethmoid Sinus Spacer Placement', 'description': 'Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ethmoid Sinus Spacer Placement', 'description': 'Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2007-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2010-01-20', 'resultsFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-01-21', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-08', 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant', 'timeFrame': 'Procedural and 6 weeks post-implant'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures', 'timeFrame': '1 wk, 2wk, 4wk, 6wk'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sinusitis, Chronic Rhinosinusitis']}, 'descriptionModule': {'briefSummary': 'Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 21 years old\n2. Both male and female\n3. Ethmoid disease on CT scan\n4. At least one non-ethmoid sinus requiring treatment\n5. Failed medical management and symptomatic\n\nExclusion Criteria:\n\n1. Previous ethmoid surgery\n2. Not sufficient room for placement of Spacer\n3. Patient requires septoplasty\n4. Has received steroid treatment with in 2 weeks\n5. Extensive sinonasal osteoneogenesis preventing device placement\n6. Sinonasal tumors or obstructive lesions\n7. History of facial trauma that distorts sinus anatomy\n8. Asthmatic patients with aspirin sensitivity\n9. Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT01054703', 'acronym': 'SPACER', 'briefTitle': 'Clinical Evaluation of the Ethmoid Sinus Spacer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)', 'orgStudyIdInfo': {'id': 'CPR02082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ethmoid Sinus Spacer placement', 'description': 'Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40', 'interventionNames': ['Device: Ethmoid Sinus Spacer']}], 'interventions': [{'name': 'Ethmoid Sinus Spacer', 'type': 'DEVICE', 'otherNames': ['Acclarent Ethmoid Sinus Spacer and Access System'], 'description': 'Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40', 'armGroupLabels': ['Ethmoid Sinus Spacer placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Nasal and Sinus Institute', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}], 'overallOfficials': [{'name': 'Fred Kuhn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia Nasal and Sinus Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Acclarent', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}