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

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

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.

Study Overview

• Status: Completed
• Conditions: Otitis Media; Ear Infection
• Intervention / Treatment: Device: Hummingbird Tympanostomy Tube System (H-TTS)

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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Cedars-Sinai Medical Care Foundation
  • Florida
    • Orlando, Florida, United States, 32835
      • Children's Ear Nose Throat & Allergy
  • Minnesota
    • Bloomington, Minnesota, United States, 55425-4516
      • HealthPartners Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Ear, Nose & Throat
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet
  • North Dakota
    • Bismarck, North Dakota, United States, 58503-0697
      • Prairie Sinus Ear & Allergy, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hummingbird Tympanostomy Tube System (H-TTS); 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.	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.; Other Names: H-TTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Preceptis Medical, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Precepts Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: Preceptis Pivotal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No