In-Office Study of the Hummingbird® in Children 2-21 Years Old

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    80
  • sponsor
    Preceptis Medical, Inc.
Updated on 1 May 2022
local anesthetic
local anesthesia
tube placement
tympanostomy tube insertion

Summary

The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children 2-21 undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

Description

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 6-24 months old. 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. The H-TTS has been cleared by the FDA for use in adults in all settings, for children in a hospital or ASC setting under both general anesthesia and moderate (conscious) sedation and in an office setting for children 6-24 months old.

The study is a continuation of a multi-site, prospective, treatment-only study of the H-TTS in children ages 2-21 years old. The study is no longer recruiting children ages 6-24 months due to receiving FDA clearance in this age group. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. 60 to 80 patients will be included at 3-10 clinical sites.

Details
Condition Ear Infection, Otitis Media
Treatment Hummingbird Tympanostomy Tube System (H-TTS)
Clinical Study IdentifierNCT03544138
SponsorPreceptis Medical, Inc.
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Scheduled to undergo tympanostomy tube insertion in the clinic
Children 2 to 21 years old
Signed parental consent, and child assent documents as applicable
Parent is fluent in English

Exclusion Criteria

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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