NCT02165384

Hummingbird TTS Ear Tube Delivery Study

Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Preceptis Medical, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Otitis Media

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2014-06-17
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

4 sites across 1 country: United States