In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old

Not Applicable

Completed

Brief 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.

Detailed 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. 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Hummingbird Tympanostomy Tube System (H-TTS)	Hummingbird Tympanostomy Tube System (H-TTS)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Successful Completion of Procedure In-office	Intra-procedure	Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.
Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up	Follow-up between 3-10 weeks	AEs that occurred from enrollment through the 3-10 week follow-up were collected.
Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS	Intra-Procedure	Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Cedars-Sinai Medical Care Foundation
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Beverly Hills, California, United States
Children's Ear Nose Throat & Allergy
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Orlando, Florida, United States
HealthPartners Institute
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Bloomington, Minnesota, United States
Mayo Clinic
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Rochester, Minnesota, United States
St. Cloud Ear, Nose & Throat
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Saint Cloud, Minnesota, United States
Park Nicollet
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Saint Louis Park, Minnesota, United States
Prairie Sinus Ear & Allergy, P.C.
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Bismarck, North Dakota, United States