Evaluation of the Tympanostomy Tube Delivery System

Completed · Phase 2/Phase 3

Conditions studied: Otitis Media With Effusion, Acute Otitis Media

In brief

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.

Key facts

Study ID

NCT01202578

Run by

Integra LifeSciences Corporation

People needed

53

Starts

2010-09-01

Expected to finish

2010-12-01

Last updated by the study team

2024-08-06

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion

You may not qualify if…

• 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

Where it is running

• South Coast ENT — Port Saint Lucie, Florida, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• Ear Medical Group — San Antonio, Texas, United States
• Evergreen Sinus Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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