Status:
COMPLETED
Evaluation of the Tympanostomy Tube Delivery System
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Otitis Media With Effusion
Acute Otitis Media
Eligibility:
All Genders
6+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Eligibility Criteria
Inclusion
- Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion
Exclusion
- Reaction to anesthesia
- Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology requiring T-tubes
- Stenosed ear canal
- Anatomy that precludes visualization and access to tympanic membrane
- Anatomy that necessitates tympanostomy tube placement in posterior half of membrane
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01202578
Start Date
September 1 2010
End Date
December 1 2010
Last Update
August 6 2024
Active Locations (4)
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1
South Coast ENT
Port Saint Lucie, Florida, United States, 34952
2
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
3
Ear Medical Group
San Antonio, Texas, United States, 78240
4
Evergreen Sinus Center
Kirkland, Washington, United States, 98034