In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old

Otitis Media Clinical Trial

Official title:

Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544138
• Other study ID #: Preceptis Pivotal
• Status: Completed
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: September 12, 2022

Study information

• Verified date: November 2022
• Source: Preceptis Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

Description:

The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.

The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children.

Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: September 12, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

Inclusion Criteria:

• Scheduled to undergo tympanostomy tube insertion in the clinic.

• Children 6 months to 21 years old

• Signed parental consent, and child assent documents as applicable.

• Parent is fluent in English.

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).

• Anatomy precludes sufficient visualization and access to the tympanic membrane.

Related Conditions & MeSH terms

• Ear Infection
• Otitis
• Otitis Media

Intervention

Device:
• Hummingbird Tympanostomy Tube System (H-TTS)
The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Care Foundation	Beverly Hills	California
United States	Prairie Sinus Ear & Allergy, P.C.	Bismarck	North Dakota
United States	HealthPartners Institute	Bloomington	Minnesota
United States	Children's Ear Nose Throat & Allergy	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Cloud Ear, Nose & Throat	Saint Cloud	Minnesota
United States	Park Nicollet	Saint Louis Park	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	Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up	AEs that occurred from enrollment through the 3-10 week follow-up were collected.	Follow-up between 3-10 weeks
Primary	Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS	Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.	Intra-Procedure
Primary	Percentage of Participants With Successful Completion of Procedure In-office	Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.	Intra-procedure

External Links

•   Precepts Medical, Inc.