Hummingbird TTS Ear Tube Delivery Study

Study Overview
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Brief Summary
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The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

Detailed Description
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The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.

Official Title
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Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer

Conditions
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Otitis Media

Intervention / Treatment
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* Device: Ear tube placement with the Hummingbird TTS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo tympanostomy tube insertion. At least 6 months old. Subject is able and willing to comply with follow-up requirements. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable. Exclusion Criteria: Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy) Significantly atrophic tympanic membrane. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea. Anatomy precludes sufficient visualization and access to the tympanic membrane.

Ages Eligible for Study
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Minimum Age: 6 Months

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 |
| --- | --- |
| Experimental: Hummingbird TTS<br>Ear tube placement with the Hummingbird TTS | Device: Ear tube placement with the Hummingbird TTS<br>* Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.<br>* Other names: Hummingbird TTS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane | Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed. | intra operative | 
| Number of Participants With Intra-operative Adverse Events | Any intra-operative adverse events, anticipated or unanticipated | Intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tympanostomy, myringotomy, otitis media, ear tubes, ear infection