Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT00941993
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lenglan1@its.jnj.com', 'phone': '650-687-5888', 'title': 'Clinical Director', 'organization': 'Acclarent'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 day (day of procedure)', 'eventGroups': [{'id': 'EG000', 'title': 'Anesthesia', 'description': 'tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.', 'otherNumAtRisk': 109, 'otherNumAffected': 2, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Erythema at return electrode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia', 'description': 'tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '94.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia', 'description': 'tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': "Includes all subjects for whom Iontophoresis current delivery was initiated.\n\nThe Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.\n\nThe Wong-Baker scores are reported by subject.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.'}, {'type': 'SECONDARY', 'title': 'Subject/Parent Reported Satisfaction With the In-office Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia', 'description': 'tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': "Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported.\n\nThe analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period.", 'unitOfMeasure': '% adult subjects or parents', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia', 'description': 'tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': "The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.\n\nPain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted'}, {'type': 'PRIMARY', 'title': 'Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia', 'description': 'tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'classes': [{'title': 'Vertigo', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mild erythema at return electrode', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iontophoretic Delivery of Local Anesthesia', 'description': 'Tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Iontophoretic Delivery of Anesthesia', 'description': 'Tympanic membrane anesthesia delivery system\n\nIontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '22.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2009-07-14', 'resultsFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-02', 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.', 'timeFrame': 'Day 0', 'description': "The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.\n\nPain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears."}], 'primaryOutcomes': [{'measure': 'Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment', 'timeFrame': 'Day 0', 'description': 'Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.'}, {'measure': 'Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale', 'timeFrame': 'Day 0', 'description': "Includes all subjects for whom Iontophoresis current delivery was initiated.\n\nThe Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.\n\nThe Wong-Baker scores are reported by subject."}, {'measure': 'Subject/Parent Reported Satisfaction With the In-office Procedure', 'timeFrame': 'Day 0', 'description': "Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported.\n\nThe analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Otitis Media', 'Chronic Otitis Media', 'Recurrent Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 12 months and older\n2. Both male and female patients eligible\n3. Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)\n\nExclusion Criteria:\n\n1. Patients with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type or any component of the drug solution\n2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane\n3. Otitis externa\n4. Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)\n5. Damaged or denuded skin in the auditory canal\n6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane'}, 'identificationModule': {'nctId': 'NCT00941993', 'acronym': 'IONTO', 'briefTitle': 'Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)', 'orgStudyIdInfo': {'id': 'CPR005000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'local anesthesia', 'description': 'tympanic membrane local anesthesia delivery system', 'interventionNames': ['Device: Iontophoresis System (Acclarent)']}], 'interventions': [{'name': 'Iontophoresis System (Acclarent)', 'type': 'DEVICE', 'otherNames': ['Acclarent'], 'description': 'Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.', 'armGroupLabels': ['local anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg ENT', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Henry "Fritz" Butehorn, III, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spartanburg ENT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Acclarent', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}