Status:
COMPLETED
Tympanostomy Tube Placement in Children in the Office (Inova Study)
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Otitis Media
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
Eligibility Criteria
Inclusion
- Scheduled to undergo tympanostomy tube insertion
- At least 6 months old and younger than 22 years 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
- Pregnant or lactating females
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01496287
Start Date
December 1 2011
End Date
April 1 2012
Last Update
August 6 2024
Active Locations (1)
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1
South Coast Ear, Nose & Throat
Port Saint Lucie, Florida, United States, 34952