N/A
Completed N=199
Hummingbird TTS Ear Tube Delivery Study
Source: ClinicalTrials.gov NCT02165384 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane — 393 Ears
Summary
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane |
393 | — |
| PRIMARY Number of Participants With Intra-operative Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo tympanostomy tube insertion.
- At least 6 months old.
- Subject is able and willing to comply with follow-up requirements.
- Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.
Exclusion Criteria
- Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
- Significantly atrophic tympanic membrane.
- Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
- Anatomy precludes sufficient visualization and access to the tympanic membrane.
Data sourced from ClinicalTrials.gov (NCT02165384). 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.