At a glance
ClinicalIndex Comparison RecordN/ACompleted· 258 enrolled
Drug / intervention
Hummingbird Tympanostomy Tube System (H-TTS)device
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.
Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
In Brief
A clinical study evaluating Hummingbird Tympanostomy Tube System (H-TTS) for Ear Infection and Otitis Media. Completed, enrolled 258 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEar Infection, Otitis Media
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJul 2018
Primary CompletionSep 2022
Study CompletionSep 2022
TodayJul 2026
First PostedJun 1, 2018
Enrollment StartJul 24, 2018
Primary CompletionSep 6, 2022
Study CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.1 years ago
Interventions
Hummingbird Tympanostomy Tube System (H-TTS)device
The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.