Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-09 @ 5:21 AM
Study NCT ID:
NCT04905134
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Vietnam']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'walter.lee@duke.edu', 'phone': '919-613-6407', 'title': 'Walter T. Lee, MD, MHS', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract', 'description': 'Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about their experience with the investigational scope device compared to the routine scope exam.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Participant exams', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers Using Flexible Nasopharyngoscope Prototype Device', 'description': 'Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.'}], 'classes': [{'categories': [{'title': '1=Very hard', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2=Harder', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': '3=Same', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': '4=Easier', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '5=Very Easy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'up to 15 minutes', 'description': 'Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy.', 'unitOfMeasure': 'Participant exams', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Participant exams', 'denomUnitsSelected': 'Participant exams', 'populationDescription': 'Only applicable to the providers who conducted the exams.'}, {'type': 'SECONDARY', 'title': 'Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Participant exams', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers Using Flexible Nasopharyngoscope Prototype Device', 'description': 'Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.'}], 'classes': [{'categories': [{'title': '1=Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2=Fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3=Good', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4=Very Good', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': '5=Excellent', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 1', 'description': 'Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the SOC scope at each value.', 'unitOfMeasure': 'Participant exams', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Participant exams', 'denomUnitsSelected': 'Participant exams', 'populationDescription': 'Only applicable to the providers who conducted the exams.'}, {'type': 'SECONDARY', 'title': 'Image Quality of the Flexible Scope as Measured on a 5-point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Participant exams', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers Using Flexible Nasopharyngoscope Prototype Device', 'description': 'Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.'}], 'classes': [{'categories': [{'title': '1=Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2=Fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3=Good', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4=Very Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': '5=Excellent', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 1', 'description': 'Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the flexible scope at each value.', 'unitOfMeasure': 'Participant exams', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Participant exams', 'denomUnitsSelected': 'Participant exams', 'populationDescription': 'Only applicable to the providers who conducted the exams.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract', 'description': 'Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about their experience with the investigational scope device compared to the routine scope exam.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers Using Flexible Nasopharyngoscope Prototype Device', 'description': 'Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.'}], 'classes': [{'categories': [{'title': '1=much more', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '2=about the same', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': '3=much less', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'groupDescription': 'Flexible scope compared with the SOC scope', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Comparison made using a 3 point scale where 1=much more, 2=about the same, and 3=much less.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract', 'description': 'Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about your experience with the investigational scope device compared to the routine scope exam.'}], 'periods': [{'title': 'Exam With Standard Nasopharyngoscope', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Study device not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Exam With Study Nasopharyngoscope', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The providers who conducted the exams (n = 9) were not considered enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract', 'description': 'Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about their experience with the investigational scope device compared to the routine scope exam.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who completed the study are included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-13', 'size': 801771, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-21T09:56', 'hasProtocol': True}, {'date': '2023-09-13', 'size': 250333, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-27T09:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2021-05-24', 'resultsFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-21', 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use', 'timeFrame': 'up to 15 minutes', 'description': 'Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy.'}], 'secondaryOutcomes': [{'measure': 'Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale', 'timeFrame': 'Day 1', 'description': 'Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the SOC scope at each value.'}, {'measure': 'Image Quality of the Flexible Scope as Measured on a 5-point Scale', 'timeFrame': 'Day 1', 'description': 'Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the flexible scope at each value.'}, {'measure': 'Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope', 'timeFrame': 'Day 1'}, {'measure': 'Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope', 'timeFrame': 'Day 1', 'description': 'Comparison made using a 3 point scale where 1=much more, 2=about the same, and 3=much less.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Oral Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to develop and evaluate a low-cost, portable, flexible nasopharyngeal scope (FNS) used to assess head and neck cancers (HNC) in low resource settings. The FNS will be compared to an endoscope that is used as standard of care (SOC) in terms of ease of use, image quality, and perceived pain. The ultimate goal is to compare the ease of use between the FNS to what is used in SOC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide signed and dated informed consent form\n* Willing to comply with all study procedures and be available for the duration of the study\n* Male or female, aged 18 or older\n* Patients who clinical meet clinical criteria for SOC scope examination of the upper aerodigestive tract. This includes signs and symptoms such as dysphagia, nasal obstruction, neck mass, throat pain, and hoarseness.\n\nExclusion Criteria:\n\n* Withdrawal of consent during the study duration\n* Subjects who have complications from the SOC exam\n* Anyone unable to under the SOC exam'}, 'identificationModule': {'nctId': 'NCT04905134', 'briefTitle': 'Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Partnership to Establish a Practice Based Network to Assess for Head and Neck Cancers Using a Low-Cost Portable Flexible Nasopharyngoscope - Optimization Phase', 'orgStudyIdInfo': {'id': 'Pro00102912'}, 'secondaryIdInfos': [{'id': '1R01DE028555-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DE028555-01A1', 'type': 'NIH'}, {'id': 'Protocol Number: 22-136-E', 'type': 'OTHER', 'domain': 'NIDCR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients evaluated using flexible nasopharyngoscope prototype device', 'interventionNames': ['Device: Nasopharyngoscope']}, {'type': 'NO_INTERVENTION', 'label': 'Patients evaluated using standard of care nasopharyngoscope'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Providers using flexible nasopharyngoscope prototype device', 'interventionNames': ['Device: Nasopharyngoscope']}], 'interventions': [{'name': 'Nasopharyngoscope', 'type': 'DEVICE', 'description': 'Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.', 'armGroupLabels': ['Patients evaluated using flexible nasopharyngoscope prototype device', 'Providers using flexible nasopharyngoscope prototype device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Walter Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}