Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2011-10-31
2012-06-30
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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Tympanostomy Tube Placement
Tympanostomy tube placement (Acclarent iontophoresis device)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Interventions
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Tympanostomy tube placement (Acclarent iontophoresis device)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Eligibility Criteria
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Inclusion Criteria
* At least 6 months old
* Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
* No history of sensitivity or reaction to anesthesia chosen for the procedure
Exclusion Criteria
* Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
* Otitis externa
* Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
* Anatomy that precludes sufficient visualization of and access to the tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
6 Months
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jacob W. Zeiders, M.D.
Role: PRINCIPAL_INVESTIGATOR
South Coast Ear, Nose & Throat
Locations
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South Coast Ear, Nose, & Throat
Port Saint Lucie, Florida, United States
Countries
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Other Identifiers
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CPR005022
Identifier Type: -
Identifier Source: org_study_id
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