Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-03-01 @ 3:22 AM
Study NCT ID:
NCT03197558
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}, {'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lengland@tuskermed.com', 'phone': '(650) 223-6909', 'title': 'Laura England, PhD', 'organization': 'Tusker Medical'}, 'certainAgreement': {'otherDetails': 'PI must submit communications to Sponsor for review and comment to verify accurate content at least 30 days prior to submitting to any third party. A delay up to 90 days may be requested by Sponsor in order to file patent applications relating to an Invention if applicable. Sponsor and PI agree that any Institution Publication shall only be made after the Multicenter Publication, provided that the Multicenter Publication is submitted within 18 months after conclusion of the study at all sites.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Procedure through 3-week post-procedure follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Tube Insertion Using Tube Delivery System (TDS)', 'description': 'Active Tymbion iontophoresis and tubes using the TDS\n\nTymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 10, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Inadequate anesthesia', 'notes': 'Potentially related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear discomfort', 'notes': 'Potentially related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tube in middle ear', 'notes': 'Potentially related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'notes': 'Potentially related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Potentially related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tube occlusion', 'notes': 'Potentially related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'notes': 'Not related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otorrhea', 'notes': 'Not related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incontinence', 'notes': 'Not related to procedure, device or drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in respiration rate', 'notes': 'Not related to procedure, device or drug. Per protocol, required to report any change in respiration \\> 30% as an adverse event. These events were not clinically significant and within normal range.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tube Insertion Using Tube Delivery System (TDS)', 'description': 'Active Tymbion iontophoresis and tubes using the TDS\n\nTymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '15.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Bootstrap method', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '14.35', 'ciUpperLimit': '14.35', 'groupDescription': 'Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.'}], 'paramType': 'MEAN', 'timeFrame': 'Day of procedure (Day 0)- Immediately after tube placement', 'description': 'The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain".\n\nFollowing TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tube Insertion Using Tube Delivery System (TDS)', 'description': 'Active Tymbion iontophoresis and tubes using the TDS\n\nTymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'comment': 'Participants undergoing iontophoresis with adequate anesthesia for tube placement.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Tubes not placed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tube Insertion Using Tube Delivery System (TDS)', 'description': 'Active Tymbion iontophoresis and tubes using the TDS\n\nTymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '15.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', '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': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants for whom iontophoresis is initiated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-02', 'size': 3933236, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-16T17:29', 'hasProtocol': True}, {'date': '2017-06-26', 'size': 762080, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-16T17:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'dispFirstSubmitDate': '2019-05-29', 'completionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2017-06-20', 'dispFirstSubmitQcDate': '2019-05-29', 'resultsFirstSubmitDate': '2019-12-17', 'studyFirstSubmitQcDate': '2017-06-21', 'dispFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.', 'timeFrame': 'Day of procedure (Day 0)- Immediately after tube placement', 'description': 'The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain".\n\nFollowing TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Barotrauma;Ear', 'OME - Otitis Media With Effusion', 'AOM - Acute Otitis Media', 'Eustachian Tube Dysfunction']}, 'descriptionModule': {'briefSummary': "A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting.\n\nThis study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).", 'detailedDescription': "The objective for Group B in the study is to evaluate tolerability and safety of tympanostomy tube (TT) placement in adults following local anesthesia in a physician's clinic setting.\n\nGroup B will consist of 30 evaluable adults who require unilateral or bilateral tube insertion.\n\nThe iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).\n\nSubjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. The subject will rate the pain upon TDS tube insertion using the VAS, and the pain score will be compared to a performance goal.\n\nSafety will be evaluated post procedure and at a follow-up visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults at least 18 years of age at time of consent\n2. Indication for tympanostomy tube insertion per Clinical Practice Guideline,or indicated for tympanostomy tube insertion due to barotrauma or Eustachian tube dysfunction per AAO-HNS Clinical Indicators.\n3. Subject is able and willing to comply with the protocol and attend all study visits.\n4. Subject is able and willing to provide informed consent.\n5. Subject is able to read and understand English.\n\nExclusion Criteria by Ear:\n\n1. Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane.\n2. Perforated tympanic membrane.\n3. Otitis externa.\n4. Hemotympanum.\n5. Damaged/denuded skin in the auditory canal.\n6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal.\n7. Notable ear discomfort experienced during audiologic or otoscopic examination.\n8. Anatomy that precludes sufficient visualization of and access to the tympanic membrane.\n9. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane.\n\n General Exclusion Criteria\n10. Pregnant or lactating females\n11. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics.\n12. Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.\n13. Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)\n14. Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.\n15. Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions'}, 'identificationModule': {'nctId': 'NCT03197558', 'acronym': 'ADEPT', 'briefTitle': 'Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tusker Medical'}, 'officialTitle': 'A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Lidocaine Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting', 'orgStudyIdInfo': {'id': 'CPR007003 - Group B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tube insertion using Tube Delivery System (TDS)', 'description': 'Active Tymbion iontophoresis and tube insertion using the TDS', 'interventionNames': ['Combination Product: Tymbion Iontophoresis and Tube Delivery System (TDS)']}], 'interventions': [{'name': 'Tymbion Iontophoresis and Tube Delivery System (TDS)', 'type': 'COMBINATION_PRODUCT', 'description': 'Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.', 'armGroupLabels': ['Tube insertion using Tube Delivery System (TDS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento ENT', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95138', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Camino ENT', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Advanced ENT and Allergy', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '28105', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose and Throat Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Specialty Physician Associates', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '29078', 'city': 'Lugoff', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina ENT', 'geoPoint': {'lat': 34.22737, 'lon': -80.68925}}, {'zip': '29118', 'city': 'Orangeburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Ear, Nose and Throat', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ear Medical Group', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'David Yen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Specialty Physician Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tusker Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}