N/A
Completed N=25
Singapore Tympanostomy Tube Delivery System Study
Source: ClinicalTrials.gov NCT01046877 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. — 94.6 percentage of ears
Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. |
94.6 | — |
| SECONDARY Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure |
100 | — |
| SECONDARY Percentage of Patent Tubes |
100 | — |
| SECONDARY Percentage of Ears With Adverse Events |
0.0 | — |
Eligibility Criteria
Inclusion Criteria
- >= 1 year of age
- Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
- Either male or female -
Exclusion Criteria
- History of sensitivity or reaction to anaesthesia
- Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
- Otitis externa
- Active acute otitis media
- Thickened Tympanic Membrane
- Thick mucoid effusion (also known as "glue ear")
- Otitis media pathology requiring T-tubes -
Data sourced from ClinicalTrials.gov (NCT01046877). 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. Informational only — not medical advice.