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.
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.
| Condition | Ear Infection, Otitis Media |
|---|---|
| Treatment | Hummingbird Tympanostomy Tube System (H-TTS) |
| Clinical Study Identifier | NCT03544138 |
| Sponsor | Preceptis Medical, Inc. |
| Last Modified on | 22 March 2023 |
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