Hummingbird TTS Ear Tube Delivery Study

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Device: Ear tube placement with the Hummingbird TTS

• Registration Number: NCT02165384
• Lead Sponsor: Preceptis Medical, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-17
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Results First Submitted: 2018-11-16
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-11
• Last Update Submitted: 2018-12-11
• Results First Posted: 2019-01-03
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hummingbird TTS	Ear tube placement with the Hummingbird TTS	Ear tube placement with the Hummingbird TTS

Primary Outcome Measures

Name	Time	Method
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane	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	Intra-operative	Any intra-operative adverse events, anticipated or unanticipated

Trial Locations

Locations (4)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Fairview Maple Grove Surgery Center; 🇺🇸 Maple Grove, Minnesota, United States

University of Minnesota Masonic Children's Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States