N/A
N=29
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02150044 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Ear Outcome Success — 21 ears
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acclarent Tympanostomy Tube Delivery System (TTDS). (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ear Outcome Success |
21 | — |
| SECONDARY Procedure Success |
12 | — |
| SECONDARY Tube Retention |
21 | — |
Summary
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
Eligibility Criteria
Inclusion Criteria
- Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion
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 requiring T-tubes
- Stenosed ear canal
- 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 (NCT02150044). 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.