CompletedNot Applicable

Clinical Study of the Tympanostomy Tube Delivery System

United States16 participantsStarted 2009-03

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

Who can participate

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

Device Success

Timeframe: At procedure visit

Trial details

NCT IDNCT00939796

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06

Results submitted2014-05-07

View on ClinicalTrials.gov More Otitis Media With Effusion trials