Hummingbird TTS Ear Tube Delivery Study

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165384
• Other study ID #: Preceptis Alpha
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 1, 2018

Study information

• Verified date: December 2018
• Source: Preceptis Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

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.

Locations

Country	Name	City	State
United States	Fairview Maple Grove Surgery Center	Maple Grove	Minnesota
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Preceptis Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane	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.	intra operative
Primary	Number of Participants With Intra-operative Adverse Events	Any intra-operative adverse events, anticipated or unanticipated	Intra-operative