Hummingbird TTS Ear Tube Delivery Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02165384
Study type	Interventional
Source	Preceptis Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	January 2014
Completion date	March 1, 2018

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