Completed

Single-Pass Hummingbird Tympanostomy Tube System for Ear Drum Procedures

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Hummingbird Tympanostomy Tube System (H-TTS)

Device
Who is being recruted

Ear Diseases+1

+ Otitis

+ Otitis Media

From 6 Months to 21 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2018
See protocol details

Summary

Principal SponsorPreceptis Medical, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 24, 2018

Actual date on which the first participant was enrolled.

The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM. The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children. Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.

Official TitlePivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
NCT03544138
Principal SponsorPreceptis Medical, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

258 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesOtitisOtitis MediaOtorhinolaryngologic Diseases

Criteria

4 inclusion criteria required to participate
Scheduled to undergo tympanostomy tube insertion in the clinic.

Children 6 months to 21 years old

Signed parental consent, and child assent documents as applicable.

Parent is fluent in English.

2 exclusion criteria prevent from participating
Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).

Anatomy precludes sufficient visualization and access to the tympanic membrane.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Cedars-Sinai Medical Care Foundation

Beverly Hills, United StatesOpen Cedars-Sinai Medical Care Foundation in Google Maps
Suspended

Children's Ear Nose Throat & Allergy

Orlando, United States
Suspended

HealthPartners Institute

Bloomington, United States
Suspended

Mayo Clinic

Rochester, United States
Completed7 Study Centers