Hummingbird TTS Ear Tube Delivery Study | Clinical Trial

Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fairview Maple Grove Surgery Center, Maple Grove, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ear tube placement with the Hummingbird TTS

Device

Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.

Other names: Preceptis Medical, Inc. Tympanostomy Tube Introducer System, Hummingbird Tympanostomy Tube Delivery System, Hummingbird TTS

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Preceptis Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Jun 17, 2014
Registry last updated: Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed