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NCT03544138 · ClinicalTrials.gov registry record · NA
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
A NA study of Otitis Media and Ear Infection, sponsored by Preceptis Medical.
- Completed
- Registry status
- NA
- Development phase
- 258
- Enrollment target
- 7
- Study locations
NCT03544138: Completed NA study of Otitis Media and Ear Infection, sponsored by Preceptis Medical.
NCT03544138 is a NA study of Otitis Media and Ear Infection that has completed, run by Preceptis Medical. The registered enrollment target is 258 participants, below the 4,325-participant average among 14 other Otitis Media trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03544138, a NA study of Otitis Media and Ear Infection, has completed, sponsored by Preceptis Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 258 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
AEs that occurred from enrollment through the 3-10 week follow-up were collected.
Conditions Studied
Interventions
- DEVICE Hummingbird Tympanostomy Tube System (H-TTS)
Study Locations (7)
Minnesota
- HealthPartners Institute - Bloomington
- Mayo Clinic - Rochester
- St. Cloud Ear, Nose & Throat - Saint Cloud
- Park Nicollet - Saint Louis Park
California
- Cedars-Sinai Medical Care Foundation - Beverly Hills
Florida
- Children's Ear Nose Throat & Allergy - Orlando
North Dakota
- Prairie Sinus Ear & Allergy, P.C. - Bismarck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2022-09-12 |
| Phase | NA |
What the finished NCT03544138 record still lists
NCT03544138 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, below the 4,325-participant average among 14 other Otitis Media trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Hummingbird Tympanostomy Tube System (H-TTS) is the first listed.
NCT03544138 lists 7 locations in 4 states (Minnesota, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03544138 about?
NCT03544138 is a clinical study titled "In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old". 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.
What is the current status of trial NCT03544138?
This trial is currently completed. It is a NA study. The enrollment target is 258 participants. The study started on 2018-07-24. Estimated completion is 2022-09-12.
What conditions does trial NCT03544138 study?
This clinical trial studies the following conditions: Otitis Media, Ear Infection.
What interventions are being tested in trial NCT03544138?
The interventions under investigation include: Hummingbird Tympanostomy Tube System (H-TTS) (DEVICE).
Who is sponsoring clinical trial NCT03544138?
This trial is sponsored by Preceptis Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03544138 being conducted?
This trial has 7 study locations across California, Florida, Minnesota, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Otitis Media
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03544138's enrollment target sits among peer trials
258 5th of 14 higher than 10 of 14 other Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Otitis Media trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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COMPLETED · NA
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