In-Office Tympanostomy Tube Placement in Children (OTTER) (NCT03323736) | Clinical Trial Compass
CompletedPhase 3
In-Office Tympanostomy Tube Placement in Children (OTTER)
United States370 participantsStarted 2017-10-31
Plain-language summary
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
Who can participate
Age range6 Months ā 12 Years
SexALL
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Inclusion criteria
ā. Males or females at least 6 months old through 12 years old at time of consent
ā. Indication for tympanostomy tube insertion per Clinical Practice Guideline
ā. Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
ā. Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
ā. Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate
Exclusion criteria
ā. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
ā. Perforated tympanic membrane
ā. Otitis externa
ā. Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
ā. Hemotympanum
ā. Damaged/denuded skin in the auditory canal
ā. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal
What they're measuring
1
Procedural Success:
Timeframe: Day of Procedure (Day 0) Immediately following tube placement
2
Tube Placement Tolerability
Timeframe: Day of Procedure (Day 0) Immediately following tube placement