Hummingbird TTS Ear Tube Delivery Study
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.
Full Title of Study: “Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 1, 2018
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.
- Device: Ear tube placement with the Hummingbird TTS
- Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
Arms, Groups and Cohorts
- Experimental: Hummingbird TTS
- Ear tube placement with the Hummingbird TTS
Clinical Trial Outcome Measures
- Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
- Time Frame: intra operative
- 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.
- Number of Participants With Intra-operative Adverse Events
- Time Frame: Intra-operative
- Any intra-operative adverse events, anticipated or unanticipated
Participating in This Clinical Trial
1. Scheduled to undergo tympanostomy tube insertion. 2. At least 6 months old. 3. Subject is able and willing to comply with follow-up requirements. 4. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable. Exclusion Criteria:
1. Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy) 2. Significantly atrophic tympanic membrane. 3. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea. 4. Anatomy precludes sufficient visualization and access to the tympanic membrane.
Gender Eligibility: All
Minimum Age: 6 Months
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Preceptis Medical, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Frank Rimell, MD, Principal Investigator, Children’s Hospitals and Clinics of Minnesota
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