Clinical trial NCT03544138: In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
Official title: Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Infection
Otitis Media
Lead sponsor: Preceptis Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 258
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up
timeFrame: Follow-up between 3-10 weeks
measure: Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS
timeFrame: Intra-Procedure
measure: Percentage of Participants With Successful Completion of Procedure In-office
timeFrame: Intra-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Care Foundation
state: California
city: Orlando
country: United States
facility: Children's Ear Nose Throat & Allergy
state: Florida
city: Bloomington
country: United States
facility: HealthPartners Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Ear, Nose & Throat
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet
state: Minnesota
city: Bismarck
country: United States
facility: Prairie Sinus Ear & Allergy, P.C.
state: North Dakota
Study officials:
References:
citation: Truitt TO, Kosko JR, Nimmons GL, Raisen J, Skovlund SM, Rimell F, Cofer SA. In-office insertion tympanostomy tubes in children using single-pass device. Laryngoscope Investig Otolaryngol. 2021 Feb 2;6(2):325-331. doi: 10.1002/lio2.533. eCollection 2021 Apr.