Hummingbird TTS Ear Tube Delivery Study

Preceptis Medical

Status

Completed

Conditions

Otitis Media

Treatments

Device: Ear tube placement with the Hummingbird TTS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02165384

Preceptis Alpha

Details and patient eligibility

About

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 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.

Enrollment

199 patients

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

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.