Clinical Study of the Tympanostomy Tube Delivery System

Completed · Not applicable

Conditions studied: Otitis Media With Effusion

In brief

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 patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Key facts

Study ID

NCT00939796

Run by

Integra LifeSciences Corporation

People needed

16

Starts

2009-03-01

Expected to finish

2009-07-01

Last updated by the study team

2024-08-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
• Either male or female

You may not qualify if…

• 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

Where it is running

• Bay Area ENT — Biloxi, Mississippi, United States
• Ear Medical Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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