Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT01047904
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2010-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthetizing the Tympanic Membrane in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'X days', 'description': 'Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse effects associated with the System and the Iontophoresis procedure', 'timeFrame': 'X days', 'description': 'The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device.'}, {'measure': 'Tolerability of the iontophoresis system', 'timeFrame': 'X days', 'description': 'Subject tolerability of the iontophoresis procedure will be assessed using a pain scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Evaluate Performance and Reliability of Iontophoresis System']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\>=18 years of age\n2. Both male and female subjects are eligible.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females\n2. Subjects 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.\n3. Markedly atrophic TM\n4. Perforated TM\n5. Sclerotic TM\n6. Otitis externa\n7. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)\n8. Damaged or denuded skin in the auditory canal\n9. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane\n10. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.'}, 'identificationModule': {'nctId': 'NCT01047904', 'briefTitle': 'Anesthetizing the Tympanic Membrane in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CPR005006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iontophoresis-treated', 'description': 'Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.', 'interventionNames': ['Device: Acclarent Iontophoresis System']}], 'interventions': [{'name': 'Acclarent Iontophoresis System', 'type': 'DEVICE', 'description': 'Administration of local anesthesia using the Acclarent Iontophoresis System', 'armGroupLabels': ['Iontophoresis-treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'East Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.46883, 'lon': -122.14108}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Acclarent', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}