Anesthetizing the Tympanic Membrane in Healthy Volunteers
NCT ID: NCT01047904
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2009-08-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Iontophoresis-treated
Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.
Acclarent Iontophoresis System
Administration of local anesthesia using the Acclarent Iontophoresis System
Interventions
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Acclarent Iontophoresis System
Administration of local anesthesia using the Acclarent Iontophoresis System
Eligibility Criteria
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Inclusion Criteria
2. Both male and female subjects are eligible.
Exclusion Criteria
2. 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.
3. Markedly atrophic TM
4. Perforated TM
5. Sclerotic TM
6. Otitis externa
7. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
8. Damaged or denuded skin in the auditory canal
9. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
10. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
18 Years
ALL
Yes
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Locations
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East Palo Alto, California, United States
Countries
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Other Identifiers
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CPR005006
Identifier Type: -
Identifier Source: org_study_id
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