N/A
N=199
Hummingbird TTS Ear Tube Delivery Study
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02165384 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane — 393 Ears
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ear tube placement with the Hummingbird TTS (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Preceptis Medical, Inc.
- Primary completion
- Mar 2018
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 |
— | — |
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.
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.