Phase 3
N=53
Evaluation of the Tympanostomy Tube Delivery System
Otitis Media With Effusion · Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01202578 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Safety of Tympanostomy Tube (TT) Delivery System — 0.0 percentage of ears
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tympanostomy tube (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Tympanostomy Tube (TT) Delivery System |
0.0 | — |
| PRIMARY Device Success |
94.1 | — |
| SECONDARY Proportion of Subjects With Procedure Success |
100 | — |
| SECONDARY Tube Retention |
99.0 | — |
Summary
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion
Exclusion Criteria
- Reaction to anesthesia
- Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology requiring T-tubes
- Stenosed ear canal
- Anatomy that precludes visualization and access to tympanic membrane
- Anatomy that necessitates tympanostomy tube placement in posterior half of membrane
Data sourced from ClinicalTrials.gov (NCT01202578). 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.