N/A
Completed N=258
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
Ear Infection · Chronic Otitis Media
Source: ClinicalTrials.gov NCT03544138 ↗
Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up — 0.41 percentage of ears
Summary
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up |
0.41 | — |
| PRIMARY Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS |
97.2 | — |
| PRIMARY Percentage of Participants With Successful Completion of Procedure In-office |
98.4 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo tympanostomy tube insertion in the clinic.
- Children 6 months to 21 years old
- Signed parental consent, and child assent documents as applicable.
- Parent is fluent in English.
Exclusion Criteria
- Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
- Anatomy precludes sufficient visualization and access to the tympanic membrane.
Data sourced from ClinicalTrials.gov (NCT03544138). 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.