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
85 participants
INTERVENTIONAL
2011-01-31
2012-05-31
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
placement of tympanostomy tube under local anesthesia in office/clinic setting
Acclarent Tympanostomy Tube Delivery system (TTDS)
placement of tympanostomy tube under local anesthesia
Interventions
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Acclarent Tympanostomy Tube Delivery system (TTDS)
placement of tympanostomy tube under local anesthesia
Other Intervention Names
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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)
Exclusion Criteria
* Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
* Otitis externa
* 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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Locations
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San Antonio, Texas, United States
Countries
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Other Identifiers
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CPR005016
Identifier Type: -
Identifier Source: org_study_id
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