N/A
N=70
Tympanostomy Tube Placement in Children in the Office (Inova Study)
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01496287 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants With Procedural, Serious, and Device-Related Adverse Events — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tube Delivery System (TDS) (Device)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Procedural, Serious, and Device-Related Adverse Events |
— | — |
| PRIMARY Device Success |
114 | — |
| SECONDARY Procedure Success |
63 | — |
| SECONDARY Procedure Tolerability |
59 | — |
| SECONDARY Tube Retention |
111 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01496287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.