N/A
N=109
Study of the Hummingbird TTS™ Tympanostomy Tube System
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT03503591 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Percentage of Procedures Converted From Sedation to General Anesthesia — 12.8 percentage of procedures converted
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hummingbird Tympanostomy Tube System (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Preceptis Medical, Inc.
- Primary completion
- Aug 2021
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 |
— | — |
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.
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.