inVENT-In-Office 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:January 2011
End Date:June 2012
Contact:R. Kehl 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 System In-Office

The objective of the study is to evaluate the safety and efficacy of the Acclarent
Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under
local anesthesia 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)

Exclusion Criteria:

- History of sensitivity or reaction to anesthesia chosen for the procedure

- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane

- Otitis externa

- 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
Ear Medical Group
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
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