At a glance
ClinicalIndex Comparison RecordN/ACompleted· 109 enrolled
Drug / intervention
Hummingbird Tympanostomy Tube Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
In Brief
An observational study evaluating Hummingbird Tympanostomy Tube System for Otitis Media. Completed, enrolled 109 participants across 4 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedApr 2018
Primary CompletionAug 2021
TodayJul 2026
First PostedApr 20, 2018
Enrollment StartJan 29, 2016
Primary CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.2 years ago
Interventions
Hummingbird Tympanostomy Tube Systemdevice
Insertion of a ventilation tube under sedation and local anesthetic