N/A
N=16
Clinical Study of the Tympanostomy Tube Delivery System
Otitis Media With Effusion
Bottom Line
View on ClinicalTrials.gov: NCT00939796 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Device Success — 21 devices
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acclarent Tympanostomy Tube Delivery System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Success |
21 | — |
| SECONDARY Cross-Over to Manual Myringotomy and Tube Placement |
3 | — |
| SECONDARY Tube Retention |
24 | — |
Summary
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
- Either male or female
Exclusion Criteria
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Active acute otitis media
- Otitis media pathology
- Stenosed ear canal
Data sourced from ClinicalTrials.gov (NCT00939796). 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.