Status:
COMPLETED
Clinical Study of the Tympanostomy Tube Delivery System
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Otitis Media With Effusion
Eligibility:
All Genders
Phase:
NA
Brief Summary
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in ...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
- Either male or female
Exclusion
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology
- Stenosed ear canal
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00939796
Start Date
March 1 2009
End Date
July 1 2009
Last Update
August 6 2024
Active Locations (2)
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1
Bay Area ENT
Biloxi, Mississippi, United States, 39532
2
Ear Medical Group
San Antonio, Texas, United States, 78240