CompletedNot Applicable

Tympanostomy Tube Placement in Children in the Office (Inova Study)

United States70 participantsStarted 2011-12

Plain-language summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.

Who can participate

Age range6 Months – 21 Years

SexALL

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Inclusion criteria

✓. Scheduled to undergo tympanostomy tube insertion
✓. At least 6 months old and younger than 22 years old
✓. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
✓. No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion criteria

✕. Pregnant or lactating females
✕. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
✕. Otitis externa
✕. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
✕. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
✕. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
✕. Anatomy that precludes sufficient visualization of and access to the tympanic membrane
✕. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

What they're measuring

Number of Participants With Procedural, Serious, and Device-Related Adverse Events

Timeframe: procedure up to 2 weeks post procedure

Device Success

Timeframe: Day 0 (day of procedure)

Trial details

NCT IDNCT01496287

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04

Results submitted2014-06-26

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