N/A
Completed N=109
Study of the Hummingbird TTS™ Tympanostomy Tube System
Source: ClinicalTrials.gov NCT03503591 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Procedures Converted From Sedation to General Anesthesia — 12.8 percentage of procedures converted
Summary
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Procedures Converted From Sedation to General Anesthesia |
12.8 | — |
| PRIMARY Rate of Intra-operative Adverse Events |
— | — |
| PRIMARY Rate of Adverse Events Through Discharge |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 6 months through 5 years of age
- Candidates for ventilation tube placement
- H-TTS used under moderate sedation and local anesthetic
Data sourced from ClinicalTrials.gov (NCT03503591). 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.