Tympanostomy Tube Placement in Children in the Office (Inova Study)
Status: | Completed |
---|---|
Conditions: | Other Indications, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Other |
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 5/27/2013 |
Start Date: | December 2011 |
End Date: | May 2012 |
Contact: | Robert K Sink, Ph.D. |
Email: | rsink@its.jnj.com |
Phone: | 650-687-4820 |
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 delivered by iontophoresis in
an office/clinic setting.
Inclusion Criteria:
1. Scheduled to undergo tympanostomy tube insertion
2. At least 6 months old and younger than 22 years old
3. Behavioral capacity and cooperative temperament to undergo an awake procedure (based
on physician judgement)
4. No history of sensitivity or reaction to anesthesia chosen for the procedure
Exclusion Criteria:
1. Pregnant or lactating females
2. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
3. Otitis externa
4. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in
the auditory canal
5. Cerumen impaction resulting in a significant amount of cleaning required to visualize
the tympanic membrane
6. Electrically sensitive subjects and subjects with electrically sensitive support
systems (pacemakers, defibrillators, etc.)
7. Anatomy that precludes sufficient visualization of and access to the tympanic
membrane
8. Anatomy that necessitates tympanostomy tube placement in the posterior half of the
tympanic membrane
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