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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
199
Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
Fairview Maple Grove Surgery Center
Maple Grove, Minnesota, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
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.
Time frame: intra operative
Number of Participants With Intra-operative Adverse Events
Any intra-operative adverse events, anticipated or unanticipated
Time frame: Intra-operative
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