Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT01623050
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
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': 'emandrusov@sinusys.com', 'phone': '4084104411', 'title': 'Janie Mandrusov, Director of Pre-Clinical and Clinical Development', 'organization': 'SinuSys Corporation'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Only device related adverse events collected', 'eventGroups': [{'id': 'EG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patency of Treated Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}, {'units': 'Ostia', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post procedure', 'unitOfMeasure': 'percentage of ostia treated', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Ostia', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of osita treated'}, {'type': 'SECONDARY', 'title': 'Patency of Treated Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}, {'units': 'Ostia', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Maxillary Sinus Ostia Patency of 33 patients analyzed.', 'unitOfMeasure': 'percentage of ostia patent', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Ostia', 'denomUnitsSelected': 'Participants', 'populationDescription': 'One patient was lost to follow up'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device-related Adverse Events as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patency of Treated Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Ostia', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Maxillary Sinus Ostia Patency of 29 patients analyzed.', 'unitOfMeasure': 'percentage of ostia patent', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Ostia', 'denomUnitsSelected': 'Participants', 'populationDescription': '5 patients were lost to follow up'}, {'type': 'SECONDARY', 'title': 'Patency of Treated Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Ostia', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Maxillary Sinus Ostia of 27 patients analyzed.', 'unitOfMeasure': 'percentage of ostia patent', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Ostia', 'denomUnitsSelected': 'Participants', 'populationDescription': '7 patients were lost to follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation\n\nSinuSys Dilation System: Sinuplasty'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '16.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '36 patients were enrolled; 2 patients withdrew consent prior to treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2012-06-13', 'resultsFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-26', 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patency of Treated Area', 'timeFrame': 'Immediately post procedure'}], 'secondaryOutcomes': [{'measure': 'Patency of Treated Area', 'timeFrame': '3 months', 'description': 'Maxillary Sinus Ostia Patency of 33 patients analyzed.'}, {'measure': 'Number of Participants With Device-related Adverse Events as a Measure of Safety', 'timeFrame': '3 months'}, {'measure': 'Patency of Treated Area', 'timeFrame': '6 months', 'description': 'Maxillary Sinus Ostia Patency of 29 patients analyzed.'}, {'measure': 'Patency of Treated Area', 'timeFrame': '12 months', 'description': 'Maxillary Sinus Ostia of 27 patients analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.', 'detailedDescription': 'A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Diagnosis of chronic maxillary sinusitis\n\nExclusion Criteria:\n\n* Previous antrostomy\n* Sinonasal tumours\n* Cystic fibrosis\n* History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus\n* Pregnant or breastfeeding females\n* Currently participating in another drug or device study'}, 'identificationModule': {'nctId': 'NCT01623050', 'briefTitle': 'Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium', 'organization': {'class': 'INDUSTRY', 'fullName': 'SinuSys Corporation'}, 'officialTitle': 'SinuSys Patency of Maxillary Sinus Ostia Study', 'orgStudyIdInfo': {'id': 'SNS-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SinuSys Dilation System', 'description': 'Maxillary Sinus Dilation', 'interventionNames': ['Device: SinuSys Dilation System']}], 'interventions': [{'name': 'SinuSys Dilation System', 'type': 'DEVICE', 'description': 'Sinuplasty', 'armGroupLabels': ['SinuSys Dilation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Valley ENT', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'St. Elizabeth Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': 'BC V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital, ENT Department", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter Catalano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Elizabeth Medical Center'}, {'name': 'Amin Javer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Paul's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SinuSys Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}