Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-01 @ 4:19 PM
Study NCT ID:
NCT03390257
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
Sponsor:
Organization:
Raw JSON
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'description': 'Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy\n\n3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation\n\nNo Adverse events were reported during this study.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adverse Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3NT Flexible Endoscope', 'description': 'Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy\n\n3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation\n\nNo Adverse events were reported during this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 hours', 'description': 'Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Sinuses Accessed and Visualized Successfully', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3NT Flexible Endoscope', 'description': 'Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy\n\n3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation'}], 'classes': [{'title': 'Maxillary sinus', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}]}]}, {'title': 'Frontal sinus', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Sphenoid sinus', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed', 'unitOfMeasure': 'percentage of sinuses', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'User Satisfaction (1-bad, 5-good)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3NT Flexible Endoscope', 'description': '3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation'}], 'classes': [{'title': 'Image quality', 'categories': [{'measurements': [{'value': '4', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Lavage', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability to patient', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Maxillary sinus access', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Frontal sinus access', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Sphenoid sinus access', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Physician satisfaction questionnaire\n\n(1-bad, 5-good)', 'unitOfMeasure': 'score on a scale 1-5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3NT Flexible Endoscope', 'description': 'Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy\n\n3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation'}], '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': '3nt Flexible Endoscope', 'description': 'The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-07-03', 'size': 2458915, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-28T13:02', 'hasProtocol': True}, {'date': '2017-07-31', 'size': 516308, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-10-28T13:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2017-12-20', 'resultsFirstSubmitDate': '2020-07-19', 'studyFirstSubmitQcDate': '2017-12-28', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-07', 'studyFirstPostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Device Effects', 'timeFrame': '4 hours', 'description': 'Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy'}], 'secondaryOutcomes': [{'measure': 'Percent of Sinuses Accessed and Visualized Successfully', 'timeFrame': '1 hour', 'description': 'Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed'}, {'measure': 'User Satisfaction (1-bad, 5-good)', 'timeFrame': '1 hour', 'description': 'Physician satisfaction questionnaire\n\n(1-bad, 5-good)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Endoscopy, BSD'], 'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': '3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures', 'detailedDescription': 'The rationale behind this feasibility study is to show that access and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in conjunction with Balloon Sinus Dilation in patients suffering from symptoms attributable to sinusitis is feasible in the office and operating room settings; This is an essential step in the development of a combined dilation and visualization system that will allow visualization, dilation and lavage of the sinuses via their natural ostia during an office visit, and minimize radiation exposure, antibiotic use, multiple office visits, and cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist\n2. Patient age: adult (\\>18 years old)\n3. Patients in general good health in the opinion of the investigator as determined by medical history and physical examination\n4. A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent\n\nExclusion Criteria:\n\n1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation\n2. Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)"}, 'identificationModule': {'nctId': 'NCT03390257', 'briefTitle': 'Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD', 'organization': {'class': 'INDUSTRY', 'fullName': '3NT Medical Ltd.'}, 'officialTitle': 'Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation', 'orgStudyIdInfo': {'id': 'SD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3NT flexible endoscope', 'description': 'Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy', 'interventionNames': ['Device: 3NT flexible endoscope']}], 'interventions': [{'name': '3NT flexible endoscope', 'type': 'DEVICE', 'otherNames': ['Balloon sinus dilation'], 'description': 'The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation', 'armGroupLabels': ['3NT flexible endoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94108', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'SF Otolaryngology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '84403', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Ogden Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jacob Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SF Otolaryngology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3NT Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}