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

Study Overview
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Brief Summary
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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
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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 Title
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Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic

Conditions
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Ear Infection, Otitis Media

Intervention / Treatment
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* Device: Hummingbird Tympanostomy Tube System (H-TTS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hummingbird Tympanostomy Tube System (H-TTS)<br>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. | Device: Hummingbird Tympanostomy Tube System (H-TTS)<br>* The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.<br>* Other names: H-TTS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up | AEs that occurred from enrollment through the 3-10 week follow-up were collected. | Follow-up between 3-10 weeks | 
| Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS | Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane. | Intra-Procedure | 
| Percentage of Participants With Successful Completion of Procedure In-office | 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. | Intra-procedure |