inVENT-visIOn Study



Status:Completed
Conditions:Other Indications, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:5/3/2014
Start Date:September 2011
End Date:June 2012
Contact:Robert K Sink
Email:rsink@its.jnj.com
Phone:650-687-4820

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Trial Summary
Trial Overview
Inclusion Criteria

A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office

The objective of the study is to evaluate the safety and efficacy of the Acclarent TTDS for
the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis
in an office/clinic setting.


Inclusion Criteria:

- Scheduled to undergo tympanostomy tube insertion

- At least 6 months 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
We found this trial at
1
site
South Coast Ear, Nose, & Throat
Port St. Lucie, Florida 34952
?
mi
from
Port St. Lucie, FL
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